Product Code: BTA FDA class 2 21 CFR 878.4780

Pump, Portable, Aspiration (Manual Or Powered)

General, Plastic Surgery

The Pump, Portable, Aspiration (Manual or Powered) is a suction device used to remove fluids, blood, secretions, or other materials from surgical sites or body cavities, available in both manually operated and electrically powered configurations. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BTA, regulated under 21 CFR 878.4780 in the General and Plastic Surgery specialty. This device is eligible for third-party 510(k) review.

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510(k)s

159

FEI Numbers

Registration Numbers

Unique Applicants

112

Years Active

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Basic Information

Product Code: BTA
Device Class: FDA class 2
Regulation Number: 878.4780
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 159 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253629	Momcozy Nasal Aspirator (BN007)	May 26, 2026	Substantially Equivalent	Shenzhen Root Innovation Technology Co., Ltd.
K260134	Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)	May 15, 2026	Substantially Equivalent	Shenzhen Root Innovation Technology Co., Ltd.
K260892	Suction Pump (SU-90)	May 14, 2026	Substantially Equivalent	Shenzhen HugeMed Medical Technical Development Co., Ltd.
K260473	Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)	May 12, 2026	Substantially Equivalent	Shenzhen Kingboom Technology Co., Ltd.
K253107	Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)	Apr 14, 2026	Substantially Equivalent	Shenzhen Dongjiang Technology Co., Ltd.
K260147	Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)	Mar 13, 2026	Substantially Equivalent	Shenzhen Kingboom Technology Co., Ltd.
K251450	Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)	Jun 06, 2025	Substantially Equivalent	Shenzhen Desida Technology Co., Ltd.
K244033	Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)	May 16, 2025	Substantially Equivalent	Shenzhen Desida Technology Co., Ltd.
K251101	AIRO Suction Unit (AIRO-01)	Apr 26, 2025	Substantially Equivalent	Cro, LLC
K250697	Electric Nasal Aspirator (BC026, BC025, BC023)	Apr 23, 2025	Substantially Equivalent	Shenzhen Kingboom Technology Co., Ltd.
K241799	ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C	Mar 07, 2025	Substantially Equivalent	Atmos Medizintechnik GmbH & Co. KG
K243138	Geon (S2) Nasal Aspirator	Feb 04, 2025	Substantially Equivalent	Geon Corporation
K241852	Nasal Aspirator (NS 13)	Dec 31, 2024	Substantially Equivalent	Avita Corporation
K242028	Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)	Nov 19, 2024	Substantially Equivalent	Dongguanshi Yiyingmei Technology Co., Ltd.
K241202	Electric nasal aspirator (HTD2601US)	Jul 01, 2024	Substantially Equivalent	Hetaida Technology Co., Ltd.
K233901	Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)	Mar 20, 2024	Substantially Equivalent	Shenzhen Desida Technology Co., Ltd.
K232831	Quiver Aspiration Pump	Feb 22, 2024	Substantially Equivalent	Anoxia Medical, Inc.
K231063	SOMAVAC® 100 Sustained Vacuum System	May 12, 2023	Substantially Equivalent	Somavac Medical Solutions, Inc.
K221042	Renova RP Centesis Pump	Apr 19, 2023	Substantially Equivalent	Gi Supply, Inc.
K223373	Enivo	Apr 07, 2023	Substantially Equivalent	Aroa Biosurgery , Ltd.
K220126	Geonic Nasal Aspirator, Geonic Nasal Cleaner	Feb 02, 2023	Substantially Equivalent	Geon Corporation
K222547	Electric nasal aspirator	Oct 20, 2022	Substantially Equivalent	Shenzhen Xinlianfeng Technology Co.,Ltd
K222856	SOMAVAC 100 Sustained Vacuum System	Oct 19, 2022	Substantially Equivalent	Somavac Medical Solutions, Inc.
K221676	Exsalta	Sep 16, 2022	Substantially Equivalent	Drw Medical
K203135	Medline Vacu-line Suction Aspirator	May 04, 2021	Substantially Equivalent	Medline Industries, Inc.
K201203	Cliq Aspirator	Sep 03, 2020	Substantially Equivalent	Anest Iwata Sparmax Co., Ltd.
K180863	FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator	Dec 19, 2018	Substantially Equivalent	Taidoc Technology Corporation
K181667	Thoraguard System	Nov 29, 2018	Substantially Equivalent	Centese, Inc.
K180606	SOMAVAC Device	May 31, 2018	Substantially Equivalent	Somavac Medical Solutions, Inc.
K173389	Rex Medical Aspiration Pump	Jan 30, 2018	Substantially Equivalent	Rex Medical, L.P.
K170533	Model 330 Multifunction Aspirator	Apr 18, 2017	Substantially Equivalent	ZOLL Medical Corporation
K161002	Aprima Smartesis Centesis Pump	Sep 28, 2016	Substantially Equivalent	Cook Incorporated
K153663	Vario 8/18/ci	May 18, 2016	Substantially Equivalent	Medela AG
K153459	TACVAC	Jan 28, 2016	Substantially Equivalent	Athena Gtx
K141255	SIMEX SUBGLOTTIC ASPIRATION SYSTEM	Sep 22, 2014	Substantially Equivalent	Simex Medizintechnik GmbH
K141553	MEDELA THOPAZ+	Aug 25, 2014	Substantially Equivalent	Medela AG
K140179	EASY GO VAC	Apr 25, 2014	Substantially Equivalent	Precision Medical, Inc.
K130123	BASIC AND DOMINANT FLEX SUCTION PUMPS	Oct 11, 2013	Substantially Equivalent	Medela AG
K130210	MEDELA THOPAZ	Mar 15, 2013	Substantially Equivalent	Medela AG
K130131	EDRAIN CHEST DRAINAGE SYSTEM	Feb 28, 2013	Substantially Equivalent	Atrium Medical Corp.
K122619	EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET	Oct 02, 2012	Substantially Equivalent	Applied Medical
K103042	ATMOS E 201 THORAX AND ATMOS S 201 THORAX	Apr 15, 2011	Substantially Equivalent	Atmos, Inc.
K090379	AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES	May 26, 2010	Substantially Equivalent	Avita Corporation
K093241	V7 PORTABLE SUCTION UNITS	Apr 27, 2010	Substantially Equivalent	Hersill, S.L.
K092903	BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING	Dec 01, 2009	Substantially Equivalent	Maquet GmbH and Co. KG
K090445	ATMOS C361/C451 SUCTION PUMP	Feb 27, 2009	Substantially Equivalent	Atmos, Inc.
K080745	GENADYNE A4 POWERED SUCTION PUMP	Jul 30, 2008	Substantially Equivalent	Genadyne Biotechnologies, Inc.
K080212	MEDELA THOPAZ, MODEL 200 0288	Jul 23, 2008	Substantially Equivalent	Medela AG
K081185	MOBLVAC W.C.	May 02, 2008	Substantially Equivalent	Ohio Medical Corporation
K071607	ASA01 HEAVY DUTY SUCTION PUMP	Jun 26, 2007	Substantially Equivalent	Zhongshan A&J Medical Equipment Co., Ltd.
K062801	SMARTSUCTION SOLO DEVICE	Oct 04, 2006	Substantially Equivalent	Haemonetics Corp.
K062610	CARE-E-VAC 3	Sep 28, 2006	Substantially Equivalent	Ohio Medical Corporation
K061133	SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S	Jul 11, 2006	Substantially Equivalent	Novaspine, LLC
K061205	MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR	Jun 21, 2006	Substantially Equivalent	Medela AG
K052650	PIONEER U601 SERIES ASPIRATOR	Nov 04, 2005	Substantially Equivalent	Merits Health Products Co., Ltd.
K052626	SMARTSUCTION HARMONY DEVICE	Oct 05, 2005	Substantially Equivalent	Haemonetics Corp.
K051758	PENUMBRA ASPIRATION PUMP, MODEL 115V	Aug 17, 2005	Substantially Equivalent	Penumbra, Inc.
K043544	MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR	Jan 07, 2005	Substantially Equivalent	Medela AG
K042943	NOUVAG AG - VACUSON 40 AND VACUSON 60	Dec 17, 2004	Substantially Equivalent	NOUVAG AG
K041405	ASPIRATION PUMP, MODEL IMD-020	Sep 02, 2004	Substantially Equivalent	Industrial & Medical Design, Inc.
K041199	MEDI-PUMP ASPIRATOR, MODEL 1615	Jun 01, 2004	Substantially Equivalent	Thomas Industries
K041154	S-SCORT...JR QUICKDRAW, MODEL 2400	May 18, 2004	Substantially Equivalent	Sscor
K040239	SUPRAFLOW CONSOLE	Feb 17, 2004	Substantially Equivalent	Neomedix Corp.
K033179	MEDELA CLARIO HOME CARE PUMP	Oct 15, 2003	Substantially Equivalent	Medela AG
K021368	MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057	May 15, 2002	Substantially Equivalent	Medela AG
K013585	MEDIPORT 2000 MOBILE	Jan 28, 2002	Substantially Equivalent	Servox Medizintechnik GmbH
K013116	DURQ/ QUALIDURA	Jan 18, 2002	Substantially Equivalent	Ever-Safety Technical Service
K011601	ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX	Jun 08, 2001	Substantially Equivalent	Ardo Medical AG
K993668	LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20	Dec 20, 1999	Substantially Equivalent	Laerdal Medical A/S
K992026	SORING GMBH, SONOCA 300	Sep 23, 1999	Substantially Equivalent	Soring GmbH Medizintechnik
K984363	XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM	Feb 26, 1999	Substantially Equivalent	Xomed, Inc.
K982371	MEDCO ASPIRATOR IV	Feb 12, 1999	Substantially Equivalent	Medco Mfg.
K983552	BASIC, MEDIAN, DOMINANT, AND VARIO	Jan 07, 1999	Substantially Equivalent	Medela, Inc.
K981703	KSEA UNIMAT 45	Aug 12, 1998	Substantially Equivalent	Karl Storz Endoscopy
K981602	DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR	Jul 17, 1998	Substantially Equivalent	Sunrise Medical Hhg, Inc.
K971749	EASYGO ASPIRATOR	Apr 01, 1998	Substantially Equivalent	Precision Medical, Inc.
K980301	IP-16	Mar 24, 1998	Substantially Equivalent	Servizi Medico Estetici Italinai Srl.
K980454	LYSONIX ASPIRATION PUMP	Mar 18, 1998	Substantially Equivalent	Lysonix, Inc.
K980392	PSI-TEC ASPIRATOR	Mar 05, 1998	Substantially Equivalent	Byron Medical
K973268	MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM	Nov 26, 1997	Substantially Equivalent	Microaire Surgical Instruments, Inc.
K971107	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5	Jun 05, 1997	Substantially Equivalent	Alexander Mfg. Co.
K963775	MODEL 8800 ASPIRATOR	Mar 26, 1997	Substantially Equivalent	Medical Specifics, Inc.
K964997	S-SCORT (2500)	Mar 05, 1997	Substantially Equivalent	Sscor
K965059	CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)	Mar 04, 1997	Substantially Equivalent	Thomas Industries
K970186	GI SUPPLY PARACENTESIS PUMP	Feb 14, 1997	Substantially Equivalent	Gi Supply
K960492	SI CONTROLLER MODEL SI 500	Dec 23, 1996	Substantially Equivalent	I.C Medical, Inc.
K954287	ACI FINE NEEDLE ASPIRATION BIOPSY KIT	Nov 29, 1995	Substantially Equivalent	Advanced Cytometrix, Inc.
K954286	ACI PULSATING VACUUM PUMP SYSTEM	Nov 29, 1995	Substantially Equivalent	Advanced Cytometrix, Inc.
K954264	ACI SINGLE LUMEN BIOPSY NEEDLE	Nov 29, 1995	Substantially Equivalent	Advanced Cytometrix, Inc.
K952806	MEDI PUMP ASPIRATOR MODELS 1130 AND 1135	Oct 26, 1995	Substantially Equivalent	Thomas Industries
K953132	UIMAT PUMP	Aug 23, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K951729	MEDI - PUMP	Aug 21, 1995	Substantially Equivalent	Thomas Industries
K952103	AEROS ASPIRATOR	Jul 31, 1995	Substantially Equivalent	Aeros Instruments, Inc.
K952632	S-SCORT	Jun 16, 1995	Substantially Equivalent	Sscor
K951326	BIOPSY DEVICE ACCESSORY	May 15, 1995	Substantially Equivalent	Biopsys Medical, Inc.
K950495	SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000	May 09, 1995	Substantially Equivalent	Surgical Dynamics, Inc.
K932031	AMBU PORTABLE SUCTION UNIT	May 05, 1995	Substantially Equivalent	Ambu, Inc.
K951423	ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT	Apr 18, 1995	Substantially Equivalent	Impact Instrumentation, Inc.
K941961	605 VACU-MAX	Mar 02, 1995	Substantially Equivalent	Medical Industries America, Inc.
K944399	MEDI-PUMP	Jan 18, 1995	Substantially Equivalent	Thomas Industries
K941096	ELECTRIC VACUM PUMP	Jan 05, 1995	Substantially Equivalent	Impact Instrumentation, Inc.
K945929	S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP	Dec 22, 1994	Substantially Equivalent	Sscor
K944818	COOK ASPIRATION/IRRIGATION UNIT	Nov 08, 1994	Substantially Equivalent	Cook Urological, Inc.
K944116	FREEDOM ASPIRATOR, MODEL 6000	Sep 07, 1994	Substantially Equivalent	Stackhouse, Inc.
K933757	HAND-HELD IRRIGATION PUMP	Aug 26, 1994	Substantially Equivalent	Ximed Medical Systems
K942033	R&D BATTERIES, PART NOS. 5243, 5104, AND 5481	Jun 28, 1994	Substantially Equivalent	R & D Batteries, Inc.
K933902	MOBLVAC III	May 20, 1994	Substantially Equivalent	Aeros Instruments, Inc.
K941578	STATVAC PORTABLE SUCTION UNIT	May 18, 1994	Substantially Equivalent	Laerdal California, Inc.
K940934	LIFE VAC	May 03, 1994	Substantially Equivalent	Life Support Products, Inc.
K934976	INSTAVAC II	May 02, 1994	Substantially Equivalent	Aeros Instruments, Inc.
K931348	BATTERY PACK #1005NC	Feb 17, 1994	Substantially Equivalent	Portable Power Systems, Inc.
K932051	TOTE-L-VAC	Nov 12, 1993	Substantially Equivalent	Aeros Instruments, Inc.
K932494	PM PUMP ASPIRATOR	Oct 07, 1993	Substantially Equivalent	Precision Medical, Inc.
K926566	CARE-E-VAC	Jul 09, 1993	Unknown	Aeros Instruments, Inc.
K930549	LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000	Jun 18, 1993	Substantially Equivalent	Rustronics, Inc.
K920628	QUINEVAC EVACUATOR/ASPIRATOR	Mar 23, 1993	Substantially Equivalent	Recto Molded Products, Inc.
K922176	INTELIJET SUCTION SUPPLY	Nov 18, 1992	Substantially Equivalent	Smith & Nephew Dyonics, Inc.
K921107	AUTOVAC	Sep 17, 1992	Substantially Equivalent	Life Support Products, Inc.
K921611	MADAVAC 190	Sep 09, 1992	Substantially Equivalent	Mada Medical Products, Inc.
K910271	VACPAC PORTABLE ASPIRATION SYSTEM	Mar 20, 1991	Substantially Equivalent	Jedmed Instrument Co.
K891129	SERIES 3 GENERAL SUCTION SYSTEM	Sep 25, 1989	Substantially Equivalent	Ultravac, Inc.
K883582	VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM	Oct 03, 1988	Substantially Equivalent	Surgidyne, Inc.
K874157	LASE EVACUATOR/ASPIRATOR	Mar 21, 1988	Substantially Equivalent	Lase, Inc.
K873940	CREAT BRAND O-RISE GENERAL ASPIRATOR	Nov 25, 1987	Substantially Equivalent	Aesthetech Corp.
K873462	VAN DELLEN ASPIRATOR	Sep 25, 1987	Substantially Equivalent	Van Dellen, Ltd.
K871570	APEX ALPHA VACUUM PUMP	Aug 18, 1987	Substantially Equivalent	Apex Medical, Inc.
K870094	BUNN MODEL 530 ASPIRATOR	Mar 06, 1987	Substantially Equivalent	The John Bunn Co.
K862875	E-VAC(TM)	Nov 03, 1986	Substantially Equivalent	Laerdal California, Inc.
K862569	HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)	Aug 14, 1986	Substantially Equivalent for Some Indications	Jedmed Instrument Co.
K862751	USA ASPIRATOR	Aug 04, 1986	Substantially Equivalent for Some Indications	U. S. A. Medical Corp.
K860030	SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID	Feb 12, 1986	Substantially Equivalent	Surgidyne, Inc.
K854844	LS1000 SURGICAL ASPIRATOR II	Feb 12, 1986	Substantially Equivalent for Some Indications	Engineering, Inc.
K851560	PORTASPIR II	Dec 13, 1985	Substantially Equivalent	Roseburg SA
K853917	EGNELL COMPACT SUCTION PUMP	Nov 25, 1985	Substantially Equivalent for Some Indications	Egnell, Inc.
K853909	EGNELL UNIVERSAL SUCTION PUMP	Nov 25, 1985	Substantially Equivalent for Some Indications	Egnell, Inc.
K850946	SURGICAL ASPIRATOR	Sep 16, 1985	Substantially Equivalent for Some Indications	Medicalex
K852646	THERMATIC SUCTION PUMP	Aug 15, 1985	Substantially Equivalent	H.C.H. Products, Inc.
K844200	K.M. PRODUCTS ASPIRATOR	Jan 25, 1985	Substantially Equivalent	Km Products
K843644	STORZ ASPIRATION MACHINE SAM 5000	Nov 16, 1984	Substantially Equivalent	Storz Instrument Co.
K843693	JACOBS HIGH VACUUM SUCTION UNIT 05-2570	Oct 31, 1984	Substantially Equivalent	J. Sklar Mfg. Co., Inc.
K843750	APPARATUS, SUCTION, WARD USE, PORTAB-	Oct 11, 1984	Substantially Equivalent	H.C.H. Products, Inc.
K842204	DMI ASPIRATOR 500	Aug 10, 1984	Substantially Equivalent	Dean Medical Instruments, Inc.
K841399	BRONCHOSCOPE SUCTION UNIT	Jul 18, 1984	Substantially Equivalent	Keymed, Inc.
K841903	FRASER HARLAKE EMERG. CARE SUCTION SYS	Jun 14, 1984	Substantially Equivalent	Fraser Harlake, Inc.
K840803	GRAMS ASPIRATOR S-300	May 21, 1984	Substantially Equivalent	Grams Medical, Inc.
K840110	LAERDAL SUCTION UNIT	Mar 12, 1984	Substantially Equivalent	Laerdal Medical Corp.
K833785	EMERGENCY ASPIRATOR	Dec 22, 1983	Substantially Equivalent	Vitalograph , Ltd.
K832274	ASPIRATOR	Oct 20, 1983	Substantially Equivalent	Wells Johnson Co.
K832100	PSI SURGICAL ASPIRATOR	Oct 04, 1983	Substantially Equivalent	Advanced Biosearch Assn.
K831085	SYNEVAC VACUUM SOURCE UNIT	Jun 08, 1983	Substantially Equivalent	Synemed, Inc.
K831007	CONNECTING TUBES	May 18, 1983	Substantially Equivalent	Medovations, Inc.
K821321	SNYDER DEBRIBEMENT SYSTEM LDP-1	Aug 06, 1982	Substantially Equivalent	Snyder Laboratories, Inc.
K820739	KEYMED KEY VAC SUCTION PUMP	May 21, 1982	Substantially Equivalent	Keymed, Inc.
K820338	IMPACT, MODELS 306/307	Mar 02, 1982	Substantially Equivalent	Impact Instrumentation, Inc.
K813312	UNIVERSAL SUCTION PUMP TYPE EUS	Dec 31, 1981	Substantially Equivalent	Egnell, Inc.
K813095	GASTRIC JUICES SUCTION PUMP	Dec 09, 1981	Substantially Equivalent	Egnell, Inc.
K812020	EGNELL COMPACT, TYPE EHV	Oct 20, 1981	Substantially Equivalent	Egnell, Inc.
K810490	GOMCO SUCTION PUMP CABINET CHANGE	Mar 13, 1981	Substantially Equivalent	Allied Healthcare Products, Inc.
K791349	SYSTEC 280 INTEGRATED SUCTION SYSTEM	Sep 07, 1979	Substantially Equivalent	Stryker Corp.