Product Code: JCX FDA class 2 21 CFR 878.4780

Apparatus, Suction, Ward Use, Portable, Ac-Powered

General, Plastic Surgery

A portable AC-powered ward use suction apparatus is a compact electric suction device used at the patient bedside or in general ward settings to aspirate fluids, secretions, and other materials from wounds or body cavities during patient care. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JCX, regulated under 21 CFR 878.4780, within the General and Plastic Surgery medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: JCX
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 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250964	Protable Phlegm Suction Unit (JMA D01)	May 11, 2026	Substantially Equivalent	Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
K243638	MV Flow Aspiration Pump (MVFLOWPMP01)	Jun 13, 2025	Substantially Equivalent	Microvention
K251111	Cary	May 07, 2025	Substantially Equivalent	Excitus AS
K243418	Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing	Dec 02, 2024	Substantially Equivalent	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
K233428	Easycess Aspiration Pump	Nov 03, 2023	Substantially Equivalent	Guangzhou Easycess Medical Co.,Ltd
K222552	120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)	Dec 09, 2022	Substantially Equivalent	Stryker Instruments
K182950	Acare Suction Unit	Aug 23, 2019	Substantially Equivalent	Acare Technology Co., Ltd.
K190789	IntelliCartTM System	Apr 24, 2019	Substantially Equivalent	Dornoch Medical Systems
K190105	ZOOM Aspiration Pump	Feb 21, 2019	Substantially Equivalent	Taiwan Biomaterial Co., Ltd.
K180115	TWBM Pump	Jul 24, 2018	Substantially Equivalent	Taiwan Biomaterial Co., Ltd.
K181398	DV-300 Aspirator	Jul 23, 2018	Substantially Equivalent	Ding Hwa Co., Ltd.
K172481	IntelliCart System	Sep 14, 2017	Substantially Equivalent	Dornoch Medical Systems
K161358	Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds	Aug 03, 2017	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K162421	IntelliCartTM System	Dec 21, 2016	Substantially Equivalent	Dornoch Medical Systems
K153407	Stryker Neptune 3 Waste Management System	Apr 25, 2016	Substantially Equivalent	Stryker Corporation
K140809	CLIQ DV-300 ASPIRATOR	Jun 23, 2014	Substantially Equivalent	Ding Hwa Co., Ltd.
K140031	SUCTION PUMP	Apr 28, 2014	Substantially Equivalent	Ding Hwa Co., Ltd.
K133786	DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID	Mar 21, 2014	Substantially Equivalent	Dornoch Medical Systems, Inc.
K133196	IMPACT MODEL 323 ASPIRATOR	Mar 10, 2014	Substantially Equivalent	Impact Instrumentation, Inc.
K132308	CLIQ DV-300 ASPIRATOR	Dec 30, 2013	Substantially Equivalent	Ding Hwa Co., Ltd.
K132671	STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM	Dec 20, 2013	Substantially Equivalent	Stryker Corporation
K130001	CARE SU01A SUCTION ASPIRATOR	Jul 25, 2013	Substantially Equivalent	Foshan Care Medical Technology Co., Ltd.
K131099	AG MASS	May 13, 2013	Substantially Equivalent	Hospitech Respiration , Ltd.
K123188	DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC	Mar 04, 2013	Substantially Equivalent	Dornoch Medical Systems, Inc.
K122756	PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING	Oct 02, 2012	Substantially Equivalent	Penumbra, Inc.
K120065	PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES	Apr 03, 2012	Substantially Equivalent	Plaxtron Industrial (M) Sdn. Bhd.
K112421	EMG SUCTION UNIT	Sep 01, 2011	Substantially Equivalent	Emg Technology Co., Ltd.
K103535	VACPLUS SUCTION UNIT	Feb 24, 2011	Substantially Equivalent	Apex Medical Corp.
K102626	VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01	Nov 12, 2010	Substantially Equivalent	Vega Technologies, Inc.
K090759	BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM	Apr 01, 2009	Substantially Equivalent	Biodrain Medical, Inc.
K082762	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	Nov 12, 2008	Substantially Equivalent	Aardvark Medical
K080845	ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM	Apr 30, 2008	Substantially Equivalent	Cardinalhealth
K081047	TRANSPOSAL ULTRA SYSTEMS	Apr 29, 2008	Substantially Equivalent	Dornoch Medical Systems, Inc.
K080005	SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701	Apr 24, 2008	Substantially Equivalent	Ding Hwa Co., Ltd.
K063448	EMG AC/DC SUCTION UNIT	Nov 30, 2006	Substantially Equivalent	Emg Technology Co., Ltd.
K060277	BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM	Mar 03, 2006	Substantially Equivalent	Boehringer Laboratories
K042349	EMG MODEL SUA01 SUCTION UNIT	Dec 16, 2004	Substantially Equivalent	Emg Technology Co., Ltd.
K011725	OLYMPUS SUCTION PUMP, MODEL KV-5	Aug 31, 2001	Substantially Equivalent	Keymed (Medical & Industrial Equipment), Ltd.
K001716	REDON SET	Jul 19, 2000	Substantially Equivalent	Pfm Produkte Fur Die Medizin AG
K982304	DEVILBISS SUCTION UNIT	Sep 25, 1998	Substantially Equivalent	Sunrise Medical Hhg, Inc.
K974038	THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT	May 11, 1998	Substantially Equivalent	A & A Medical, Inc.
K963558	CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR	Dec 04, 1996	Substantially Equivalent	Contemporary Products, Inc.
K950698	LSU 2000 PORTABLE SUCTION UNIT	May 09, 1995	Substantially Equivalent	Laerdal Medical Corp.
K945062	VACPLUS	Mar 14, 1995	Substantially Equivalent	Kinetic Concepts, Inc.
K944119	SURE-FLO IRRIGATION Y TUBING SET	Dec 05, 1994	Substantially Equivalent	O.R. Resources, Inc.
K940886	ANNELID	Nov 17, 1994	Substantially Equivalent	Kinetic Concepts, Inc.
K941527	MODEL 2300 GENERAL PURPOSE SUCTION PUMP	May 18, 1994	Substantially Equivalent	Product & Educational Services
K941526	MODEL 2000 MILD INTERMITTENT SUCTION PUMP	May 18, 1994	Substantially Equivalent	Product & Educational Services
K941525	MODEL 2200 THORACIC SUCTION PUMP	May 18, 1994	Substantially Equivalent	Product & Educational Services
K941524	MODEL 2100 MILD INTERMITTENT SUCTION PUMP	May 17, 1994	Substantially Equivalent	Product & Educational Services
K935218	SCHUCO-VAC MODEL 178	Apr 05, 1994	Substantially Equivalent	Schuco, Inc.
K930852	OLYMPUS SUCTION PUMP MODEL KV-4	Mar 31, 1994	Substantially Equivalent	Keymed (Medical & Industrial Equipment), Ltd.
K930030	SUCTION TUBES: HOUSE, BARON	Feb 25, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K930900	COOK ASPIRATION UNIT	Jul 22, 1993	Substantially Equivalent	Cook Ob/Gyn
K920288	POWERED VACUUM ASPIRATOR 1110-G-062	Jun 29, 1992	Substantially Equivalent	Stirn Industries
K920287	POWERED VACUUM ASPIRATOR 1110-G-030	Jun 29, 1992	Substantially Equivalent	Stirn Industries
K914694	STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU	Jan 16, 1992	Substantially Equivalent	Depuy, Inc.
K914177	HYDRODISECTOR	Nov 29, 1991	Substantially Equivalent	Spiess Design, Inc.
K900430	IRRIGATION AND SUCTION APPARATUS	Jun 05, 1990	Substantially Equivalent	Acorn Group, Inc.
K895761	GENERAL ASPERATOR	Oct 18, 1989	Substantially Equivalent	Kolster Methods
K872094	VACU-AIDE	Oct 15, 1987	Substantially Equivalent	The Devilbiss Co.
K843081	TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT	Oct 11, 1984	Substantially Equivalent	Creative Medical Laboratories, Inc.
K842050	IMPACT MODEL 316	Aug 03, 1984	Substantially Equivalent	Impact Instrumentation, Inc.
K841538	IMPACT MODEL 308	Jun 11, 1984	Substantially Equivalent	Impact Instrumentation, Inc.
K841160	MORWEL ASPIRATOR	May 31, 1984	Substantially Equivalent	Morwel Corp.
K832301	DIRECT BONDED BRACKET REMOVER	Aug 31, 1983	Substantially Equivalent	Northwest Orthopedics
K820331	IMPACT, MODEL 302	Feb 23, 1982	Substantially Equivalent	Impact Instrumentation, Inc.
K820330	IMPACT, MODEL E-12	Feb 23, 1982	Substantially Equivalent	Impact Instrumentation, Inc.
K801349	LOSEFF BALLOON TYPE SELF-RETENTION WOUND	Aug 07, 1980	Substantially Equivalent	Loseff Medical Designers, Ltd.
K801043	E-VAX CHEST DRAINAGE SYSTEM	Jun 20, 1980	Substantially Equivalent	Cardio Surgical Concepts, Inc.
K792592	AMBU UNIVERSAL SUCTION PUMP	Jan 11, 1980	Substantially Equivalent	Narco Air-Shields
K791241	BRIOX MODEL 2000-CA COMPRESSOR UNIT	Jul 24, 1979	Substantially Equivalent	Briox Technologies, Inc.
K791240	BRIOX MODEL 2000-C COMPRESSOR UNIT	Jul 24, 1979	Substantially Equivalent	Briox Technologies, Inc.
K791239	BRIOX MODEL 2000-A ASPIRATOR UNIT	Jul 24, 1979	Substantially Equivalent	Briox Technologies, Inc.
K791238	BRIOX MODEL 2000-CQ QUIET COMPRESSOR	Jul 24, 1979	Substantially Equivalent	Briox Technologies, Inc.
K791210	PORTABLE ASPIRATOR	Jul 24, 1979	Substantially Equivalent	Sam Say Assoc.
K771071	PORTO-VAC	Jul 14, 1977	Substantially Equivalent	Cpac, Inc.