Atlas FDA

FYD

75 FDA 510(k) clearances · Product code

176 daysmedian time to decision
328 days90th percentile
75clearances measured

FDA profile

Official device name
Apparatus, Exhaust, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5070
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 71 · 2015: 21 · 2020: 11 · 2021: 20 · 2022: 46 · 2023: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PlumeSafe X5 Smoke Management System (K240127)Conmed Corporation2024-08-05
8Q10 Surclear Smoke Plume Evacuation System (K233789)Surnic Corporation2024-04-10
Medline Smoke Evacuation Shroud (K213068)Medline Industries, Inc.2022-01-03
NEBULAE SRS Laparoscopic Surgical Smoke Removal System (K202944)Northgate Technologies, Inc.2021-03-25
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor (K200250)Megadyne Medical Products, Inc.2020-06-26
EvaQMax Smoke Evacuation System (K192035)Bio Protech, Inc.2019-08-29
Megadyne Foot Switch (K191328)Megadyne Medical Products, Inc.2019-07-26
SafeAir Smoke Evacuator compact (K182224)Lina Medical Aps2019-02-07
Smoklean (K173108)Sejong Medical Co., Ltd.2018-05-18
Crystal Vision (K163659)I.C Medical, Inc.2017-10-30
RapidVac Smoke Evacuator System (K142335)Covidien2015-01-14
VISICLEAR SMOKE EVACUATION SYSTEM (K131402)Buffalo Filter Co., Inc.2014-03-03
CONMED AER DEFENSE SMOKE EVACUATOR (K091139)Conmed Corporation2009-05-05
SERVICE MANAGER SM40SE (K053464)Conmed Integrated Systems, Canada, Ulc2006-06-06
LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM (K052797)Medtek Devices, Inc.2006-02-13
MASTEL LASER CLEAN ROOM, MODEL EBS-100 (K043494)Mastel Precision Surgical Instruments, Inc.2005-10-04
LAFACI (K032400)Vision Pro, LLC2004-05-07
SMOKE EVACUATION HOSES/TUBING (K020510)Dm Medical, Inc.2002-05-03
NEPTUNE WASTE MANAGEMENT STSTEM (K012991)Stryker Instruments2001-11-29
CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES (K003840)I.C Medical, Inc.2001-02-01
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 (K001082)Stackhouse, Inc.2000-06-15
PENADAPT 10 (K000904)Buffalo Filter Co., Inc.2000-06-08
NEPTUNE WASTE MANAGEMENT SYSTEM (K990037)American Immuno Tech1999-08-24
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 (K992361)Pall Medical1999-08-20
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF (K983298)Buffalo Filter Co., Inc.1999-08-16
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 (K983333)Buffalo Filter Co., Inc.1999-08-11
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 (K983364)Buffalo Filter Co., Inc.1999-08-11
STERIS SMOKE EVACUATION SYSTEM (K991167)STERIS Corporation1999-06-03
VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM (K980915)Valleylab, Inc.1998-06-29
SKYVAL (K973610)Pyramid Air Systems1997-12-19
SMARTVAC SMOKE EVACUATION SYSTEM (K970352)Isomedix Operations, Inc.1997-11-04
FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC (K952981)Utah Medical Products, Inc.1995-08-28
BUFFALO FILTER REPLACEMENT FILTER #BSPF030 (K943226)Buffalo Filter Co., Inc.1995-07-10
BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 (K943227)Buffalo Filter Co., Inc.1995-07-07
BEI MEDICAL SYSTEMS' SMOKE EVACUATOR (K940266)Bei Medical Systems Co., Inc.1994-03-24
SNJ SMOKE EVACUATION SUCTION WAND (K935439)Lca, Inc.1994-03-07
CRYSTAL VISION AND ACCESSORIES (K932230)I.C Medical, Inc.1994-02-18
ACU-EVAC (K930043)Acuderm, Inc.1994-02-09
BUFFALO FILTER REPLACEMENT FILTER #BPTU100 (K930058)Buffalo Filter Co., Inc.1993-11-30
BUFFALO FILTER REPLACEMENT FILTER #BST300UL (K930062)Buffalo Filter Co., Inc.1993-11-30
REUSABLE TOWEL AND GOWN PACKS (K930167)Custom Sterile Services, Inc.1993-11-30
PLUMEMASTER SMOKE EVACUATION SYSTEM (K930434)Sorenson Laboratories, Inc.1993-11-16
BUFFALO FILTER REPLACEMENT FILTER #BCULPA (K930063)Buffalo Filter Co., Inc.1993-11-12
BUFFALO FILTER REPLACEMENT FILTER #BCCHAR (K930066)Buffalo Filter Co., Inc.1993-11-12
BUFFALO FILTER REPLACEMENT FILTER #BCR0030 (K930064)Buffalo Filter Co., Inc.1993-11-12
BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO (K930060)Buffalo Filter Co., Inc.1993-11-12
BUFFALO FILTER REPLACEMENT FILTER #BCR0043 (K930065)Buffalo Filter Co., Inc.1993-11-12
VICROSAFE 6 AND VICROSAFE 12 (K930041)Buffalo Filter Co., Inc.1993-11-03
BUFFALO FILTER REPLACEMENT #BLFS-101/103 (K930040)Buffalo Filter Co., Inc.1993-11-02
BUFFALO FILTER REPLACEMENT FILTER BST312PF (K930061)Buffalo Filter Co., Inc.1993-11-02
BUFFALO FILTER REPLACEMENT FILTER #BSTM300 (K930059)Buffalo Filter Co., Inc.1993-10-29
BUFFALO FILTER REPLACEMENT FILTER #BILF-100 (K930450)Buffalo Filter Co., Inc.1993-10-29
PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM (K924731)Buffalo Filter Co., Inc.1993-09-13
PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM (K924732)Buffalo Filter Co., Inc.1993-09-13
QUINEVAC II (K920629)Recto Molded Products, Inc.1993-03-24
SMOKE EATER (K923799)Nordex Medical Corp.1993-01-29
ENVIROMATE(TM) SMOKE EVACUATION SYSTEM (K922555)Lase, Inc.1993-01-06
SRH-678 VACCUUM TUBING (K920210)Quinn Healthcare Products1992-10-01
CRF CHARCOAL CANISTER REPLACEMENT FILTER (K920209)Quinn Healthcare Products1992-10-01
HPM REPLACEMENT ULPA FILTER MODEL UF001 (K920371)Hpm Ent.1992-08-12
I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR (K914118)I.C Medical, Inc.1992-02-12
SMOKE/ODOR EVACUATOR #757 (K912612)Olsen Electrosurgical, Inc.1991-11-01
BIPURE 1000 (K912347)Laser Engineering, Inc.1991-09-23
PLUME MASTER (K913036)Sorex Medical1991-09-06
PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM) (K912853)Precision Laser Products, Inc.1991-08-20
SURG/ASSIST MODEL SA-1 (K912422)Surg-Assist, Inc.1991-08-12
SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 (K911154)Sun Medical, Inc.1991-07-26
AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM (K912651)Stackhouse Assoc.1991-07-08
I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR (K902611)I.C Medical, Inc.1990-08-17
SURGISMOKE (K896822)Spectro Industries, Inc.1990-01-11
SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 (K894765)Laser Industries , Ltd.1989-09-28
PLUME-AWAY SMOKE EVACUATION SYSTEM (K894038)Laser Technologies Group, Inc.1989-09-28
THE S.A.F.E. SYSTEM (K880890)Pfizer Laser Systems1988-05-11
MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM (K874512)Stackhouse Assoc.1988-01-27
XANAR MODEL XSE-300 SMOKE EVACULATER (K844087)Xanar, Inc.1985-02-27

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Every clearance here is in the API, with alerts when new ones post.