Atlas FDA

FEQ

21 FDA 510(k) clearances · Product code

50 daysmedian time to decision
166 days90th percentile
21clearances measured

FDA profile

Official device name
Pump, Air, Non-Manual, For Endoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2000: 2 · 2018: 22 · 2022: 19 · 2024: 705 · 2025: 344 · 2026: 182
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EndoGator Endoscopy Irrigation Tubing (K220395)STERIS Corporation2022-03-11
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM (K191559)United States Endoscopy Group, Inc.2019-08-01
AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm (K182258)United States Endoscopy Group, Inc.2018-09-21
AquaShield System CO2- Fujifilm (K173650)United States Endoscopy Group, Inc.2018-01-05
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON (K163424)United State Endoscopy Group, Inc.2017-01-04
Erbe’s CO2 Tubing/Cap Sets (K162152)Erbe USA, Inc.2016-08-31
EndoChoice Water Bottle Cap Irrigation System (K161482)Endochoice, Inc.2016-06-27
EndoChoice Water Bottle Cap System (K153588)Endochoice, Inc.2016-02-24
AquaShield system CO2, AquaShield system-PENTAX (K153362)United States Endoscopy Group, Inc.2015-12-16
ENDOCHOICE WATER BOTTLE CAP SYSTEM (K142155)Endochoice, Inc.2015-01-20
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM (K133747)Endochoice, Inc.2014-01-08
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 (K132340)Erbe USA, Inc.2013-12-17
WATER BOTTLE CAP IRRIGATON SYSTEM (K120862)Endochoice, Inc.2012-11-27
AQUASHIELD CO2 SYSTEM (K120123)United States Endoscopy Group, Inc.2012-03-28
ENDOCHOICE WATER BOTTLE CAP SYSTEM (K112576)Endochoice, Inc.2012-01-25
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES (K103696)Erbe USA, Inc.2011-03-22
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (K100899)Keymed (Medical & Industrial Equipment), Ltd.2010-09-13
WATER BOTTLE CAP SYSTEM (K101146)United States Endoscopy Group, Inc.2010-07-16
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (K100803)Keymed, Inc.2010-04-22
ENDOGATOR (K092429)Byrne Medical, Inc.2009-11-19
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 (K000948)Keymed (Medical & Industrial Equipment), Ltd.2000-05-12

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