Atlas FDA

FEB

57 FDA 510(k) clearances · Product code

111 daysmedian time to decision
385 days90th percentile
57clearances measured

FDA profile

Official device name
Accessories, Cleaning, For Endoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 575 · 2022: 607 · 2023: 998 · 2024: 884 · 2025: 361 · 2026: 266
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
System 83 Revolve Endoscope Washer/Disinfector (K241168)Wassenburg Medical, Inc.2024-12-19
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433)STERIS Corporation2024-12-02
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (K230930)STERIS Corporation2023-06-30
SCOPE BUDDY PLUS Endoscope Flushing Aid (K213833)Medivators, Inc.2022-01-14
Endoscope Reprocessor OER-Elite (K201920)Olympus Medical Systems Corp.2020-09-01
System 83 Plus Washer/Disinfector (K173590)Custom Ultrasonics, Inc.2020-03-30
ENDOSCOPE REPROCESSOR OER-Elite (K190969)Olympus Medical Systems Corp.2019-07-09
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (K181472)Advanced Sterilization Products (Asp)2019-04-23
Acu-sInQ Complete Endoscope Cleaning Aid System (K181865)STERIS Corporation2018-12-14
Advantage Plus Pass-Thru (K172677)Medivators, Inc.2017-12-19
Scope-Assist Flushing Sink (K162120)Custom Ultrasonics, Inc.2017-04-28
Scope Buddy Plus Endoscope Flushing Aid (K162128)Medivators, Inc.2016-12-21
EVOTECH ECR (K152189)Advanced Sterilization Products (Asp)2016-07-20
EVOTECH ECR (K140977)Advanced Sterilization Products2014-12-22
SYSTEM 83 PLUS (K122172)Custom Ultrasonics2013-01-25
ENDOSCOPE REPROCESSOR OER-MINI (K120357)Olympus Medical Systems Corp.2012-12-20
LIC INSTRUMENT PROCESSING SYSTEM (K101158)Langford IC Systems, Inc.2011-05-06
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO (K103264)Olympus Medical Systems Corporation2011-02-23
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR (K102996)Medivators Reprocessing Systems2011-01-13
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM (K092387)Minntech Corp.2010-04-05
ENDOSCOPE REPROCESSOR OER-PRO (K093106)Olympus Medical Systems Corporation2010-02-12
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT (K082988)Medivators Reprocessing Systems2009-02-13
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR (K082392)Advanced Sterilization Products2008-11-13
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING (K063876)Medivators Reprocessing Systems2007-06-14
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR (K061430)Custom Ultrasonics2007-01-12
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM (K061899)Advanced Sterilization Products2006-10-26
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR (K060458)Langford IC Systems, Inc.2006-10-12
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM (K040883)Advanced Sterilization Products2005-03-15
RIWO SYSTEM TRAYS (K012309)Richard Wolf Medical Instruments Corp.2001-10-19
PSK ENDOSCOPE CLEANING SYSTEM (K000216)Psk Connectors Pty, Ltd.2000-05-09
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) (K973558)Ultracell Medical Technologies, Inc.1997-11-24
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS (K964871)Biosearch Medical Products, Inc.1997-03-03
VIRAPUMP II (MODELS AND MODEL M) (K961607)Viatro, Corp.1996-12-06
MILL-ROSE RIGID SCOPE CLEANING BRUSHES (K954745)Mill-Rose Laboratory1995-11-27
EW-10 AND EW-20 (K915402)Olympus Corp.1995-06-23
CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT (K944776)Blue Planet Industries, Inc.1994-11-01
AUTO SUTURE* ANTI-FOG DEVICE** (K944249)United States Surgical, A Division of Tyco Healthc1994-09-20
BLUE PLANET LENS FOG REDUCTION & CLEANING KIT (K941648)Blue Planet Industries, Inc.1994-05-17
EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT (K941134)H & C Chemical, Inc.1994-05-16
FLUID PUMP, CP #3 (K914524)United States Endoscopy Group, Inc.1994-03-09
DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES (K914145)Medivators, Inc.1994-02-22
ENDOWASH (K915620)Novar Medical Industries1993-12-02
HOBBS MEDICAL CLEANING BRUSH (K933354)Hobbs Medical, Inc.1993-10-28
CANDELA MINIBRUSH (K932930)Candela Laser Corp.1993-10-05
FLEXIBLE URETERONEPHROSOCOPE (K924135)Applied Medical Resources1993-04-14
OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 (K921179)Keymed, Inc.1993-03-29
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (K924655)Cox Medical Ent., Inc.1992-12-15
CLEANING BRUSH (K924103)United States Endoscopy Group, Inc.1992-11-16
ONE DIRECTIONAL CLEANING BRUSH (K923687)Endoscopy Support Services, Inc.1992-09-23
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (K923672)Cox Medical Ent., Inc.1992-09-23
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (K914442)Cox Medical Ent., Inc.1991-10-25
DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN (K901439)Telemed Systems, Inc.1990-06-11
SPARCO SCOPE GUARD (K850268)Sparco, Inc.1985-04-15
CODE 17-ENDOSCOPE DEODORANT (K840208)Knox Laboratories1984-07-19
FIBERSCOPE DISINFECTANT IRRIGATOR (K830026)Keymed, Inc.1983-01-14
KEY MED LEEDS ENDOSCOPE DISINFECTOR (K820152)Keymed, Inc.1982-01-29
KEY-MED FIBRESCOPE DISINFECTION TROLLEY (K810818)Keymed, Inc.1981-04-08

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