Product Code: FYD FDA class 2 21 CFR 878.5070

Apparatus, Exhaust, Surgical

General, Plastic Surgery

A surgical exhaust apparatus is a ventilation device used in operating rooms to remove contaminated air, particulate matter, aerosols, or anesthetic gases from the immediate surgical environment, improving air quality and infection control. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FYD, regulated under 21 CFR 878.5070, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: FYD
Device Class: FDA class 2
Regulation Number: 878.5070
Medical Specialty: General, Plastic Surgery
Review Panel: HO
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 75 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240127	PlumeSafe X5 Smoke Management System	Aug 05, 2024	Substantially Equivalent	Conmed Corporation
K233789	8Q10 Surclear Smoke Plume Evacuation System	Apr 10, 2024	Substantially Equivalent	Surnic Corporation
K213068	Medline Smoke Evacuation Shroud	Jan 03, 2022	Substantially Equivalent	Medline Industries, Inc.
K202944	NEBULAE SRS Laparoscopic Surgical Smoke Removal System	Mar 25, 2021	Substantially Equivalent	Northgate Technologies, Inc.
K200250	Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor	Jun 26, 2020	Substantially Equivalent	Megadyne Medical Products, Inc.
K192035	EvaQMax Smoke Evacuation System	Aug 29, 2019	Substantially Equivalent	Bio Protech, Inc.
K191328	Megadyne Foot Switch	Jul 26, 2019	Substantially Equivalent	Megadyne Medical Products, Inc.
K182224	SafeAir Smoke Evacuator compact	Feb 07, 2019	Substantially Equivalent	Lina Medical Aps
K173108	Smoklean	May 18, 2018	Substantially Equivalent	Sejong Medical Co., Ltd.
K163659	Crystal Vision	Oct 30, 2017	Substantially Equivalent	I.C Medical, Inc.
K142335	RapidVac Smoke Evacuator System	Jan 14, 2015	Substantially Equivalent	Covidien
K131402	VISICLEAR SMOKE EVACUATION SYSTEM	Mar 03, 2014	Substantially Equivalent	Buffalo Filter Co., Inc.
K091139	CONMED AER DEFENSE SMOKE EVACUATOR	May 05, 2009	Substantially Equivalent	Conmed Corporation
K053464	SERVICE MANAGER SM40SE	Jun 06, 2006	Substantially Equivalent	Conmed Integrated Systems, Canada, Ulc
K052797	LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM	Feb 13, 2006	Substantially Equivalent	Medtek Devices, Inc.
K043494	MASTEL LASER CLEAN ROOM, MODEL EBS-100	Oct 04, 2005	Substantially Equivalent	Mastel Precision Surgical Instruments, Inc.
K032400	LAFACI	May 07, 2004	Substantially Equivalent	Vision Pro, LLC
K020510	SMOKE EVACUATION HOSES/TUBING	May 03, 2002	Substantially Equivalent	Dm Medical, Inc.
K012991	NEPTUNE WASTE MANAGEMENT STSTEM	Nov 29, 2001	Substantially Equivalent	Stryker Instruments
K003840	CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES	Feb 01, 2001	Substantially Equivalent	I.C Medical, Inc.
K001082	STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100	Jun 15, 2000	Substantially Equivalent	Stackhouse, Inc.
K000904	PENADAPT 10	Jun 08, 2000	Substantially Equivalent	Buffalo Filter Co., Inc.
K990037	NEPTUNE WASTE MANAGEMENT SYSTEM	Aug 24, 1999	Substantially Equivalent	American Immuno Tech
K992361	PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1	Aug 20, 1999	Substantially Equivalent	Pall Medical
K983298	BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF	Aug 16, 1999	Substantially Equivalent	Buffalo Filter Co., Inc.
K983364	BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801	Aug 11, 1999	Substantially Equivalent	Buffalo Filter Co., Inc.
K983333	BUFFALO FILTER VIROSAFE HRF- #VSHRFO1	Aug 11, 1999	Substantially Equivalent	Buffalo Filter Co., Inc.
K991167	STERIS SMOKE EVACUATION SYSTEM	Jun 03, 1999	Substantially Equivalent	STERIS Corporation
K980915	VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM	Jun 29, 1998	Substantially Equivalent	Valleylab, Inc.
K973610	SKYVAL	Dec 19, 1997	Substantially Equivalent	Pyramid Air Systems
K970352	SMARTVAC SMOKE EVACUATION SYSTEM	Nov 04, 1997	Substantially Equivalent	Isomedix Operations, Inc.
K952981	FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC	Aug 28, 1995	Substantially Equivalent	Utah Medical Products, Inc.
K943226	BUFFALO FILTER REPLACEMENT FILTER #BSPF030	Jul 10, 1995	Substantially Equivalent	Buffalo Filter Co., Inc.
K943227	BUFFALO FILTER REPLACEMENT FILTER #BSUCF03	Jul 07, 1995	Substantially Equivalent	Buffalo Filter Co., Inc.
K940266	BEI MEDICAL SYSTEMS' SMOKE EVACUATOR	Mar 24, 1994	Substantially Equivalent	Bei Medical Systems Co., Inc.
K935439	SNJ SMOKE EVACUATION SUCTION WAND	Mar 07, 1994	Substantially Equivalent	Lca, Inc.
K932230	CRYSTAL VISION AND ACCESSORIES	Feb 18, 1994	Substantially Equivalent	I.C Medical, Inc.
K930043	ACU-EVAC	Feb 09, 1994	Substantially Equivalent	Acuderm, Inc.
K930167	REUSABLE TOWEL AND GOWN PACKS	Nov 30, 1993	Substantially Equivalent	Custom Sterile Services, Inc.
K930062	BUFFALO FILTER REPLACEMENT FILTER #BST300UL	Nov 30, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930058	BUFFALO FILTER REPLACEMENT FILTER #BPTU100	Nov 30, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930434	PLUMEMASTER SMOKE EVACUATION SYSTEM	Nov 16, 1993	Substantially Equivalent	Sorenson Laboratories, Inc.
K930066	BUFFALO FILTER REPLACEMENT FILTER #BCCHAR	Nov 12, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930065	BUFFALO FILTER REPLACEMENT FILTER #BCR0043	Nov 12, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930064	BUFFALO FILTER REPLACEMENT FILTER #BCR0030	Nov 12, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930063	BUFFALO FILTER REPLACEMENT FILTER #BCULPA	Nov 12, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930060	BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO	Nov 12, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930041	VICROSAFE 6 AND VICROSAFE 12	Nov 03, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930061	BUFFALO FILTER REPLACEMENT FILTER BST312PF	Nov 02, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930040	BUFFALO FILTER REPLACEMENT #BLFS-101/103	Nov 02, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930450	BUFFALO FILTER REPLACEMENT FILTER #BILF-100	Oct 29, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K930059	BUFFALO FILTER REPLACEMENT FILTER #BSTM300	Oct 29, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K924732	PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM	Sep 13, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K924731	PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM	Sep 13, 1993	Substantially Equivalent	Buffalo Filter Co., Inc.
K920629	QUINEVAC II	Mar 24, 1993	Substantially Equivalent	Recto Molded Products, Inc.
K923799	SMOKE EATER	Jan 29, 1993	Substantially Equivalent	Nordex Medical Corp.
K922555	ENVIROMATE(TM) SMOKE EVACUATION SYSTEM	Jan 06, 1993	Substantially Equivalent	Lase, Inc.
K920210	SRH-678 VACCUUM TUBING	Oct 01, 1992	Substantially Equivalent	Quinn Healthcare Products
K920209	CRF CHARCOAL CANISTER REPLACEMENT FILTER	Oct 01, 1992	Substantially Equivalent	Quinn Healthcare Products
K920371	HPM REPLACEMENT ULPA FILTER MODEL UF001	Aug 12, 1992	Substantially Equivalent	Hpm Ent.
K914118	I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR	Feb 12, 1992	Substantially Equivalent	I.C Medical, Inc.
K912612	SMOKE/ODOR EVACUATOR #757	Nov 01, 1991	Substantially Equivalent	Olsen Electrosurgical, Inc.
K912347	BIPURE 1000	Sep 23, 1991	Substantially Equivalent	Laser Engineering, Inc.
K913036	PLUME MASTER	Sep 06, 1991	Substantially Equivalent	Sorex Medical
K912853	PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)	Aug 20, 1991	Substantially Equivalent	Precision Laser Products, Inc.
K912422	SURG/ASSIST MODEL SA-1	Aug 12, 1991	Substantially Equivalent	Surg-Assist, Inc.
K911154	SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200	Jul 26, 1991	Substantially Equivalent	Sun Medical, Inc.
K912651	AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM	Jul 08, 1991	Substantially Equivalent	Stackhouse Assoc.
K902611	I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR	Aug 17, 1990	Substantially Equivalent	I.C Medical, Inc.
K896822	SURGISMOKE	Jan 11, 1990	Substantially Equivalent	Spectro Industries, Inc.
K894765	SHARPLAN SMOKE EVACUATION UNIT, MODEL 100	Sep 28, 1989	Substantially Equivalent	Laser Industries , Ltd.
K894038	PLUME-AWAY SMOKE EVACUATION SYSTEM	Sep 28, 1989	Substantially Equivalent	Laser Technologies Group, Inc.
K880890	THE S.A.F.E. SYSTEM	May 11, 1988	Substantially Equivalent	Pfizer Laser Systems
K874512	MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM	Jan 27, 1988	Substantially Equivalent	Stackhouse Assoc.
K844087	XANAR MODEL XSE-300 SMOKE EVACULATER	Feb 27, 1985	Substantially Equivalent	Xanar, Inc.