Atlas FDA

FCX

25 FDA 510(k) clearances · Product code

67 daysmedian time to decision
282 days90th percentile
25clearances measured

FDA profile

Official device name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 10 · 2022: 29 · 2023: 54 · 2024: 35 · 2025: 146 · 2026: 90
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
VS-370CF, VS-370CT (K262152)VISION MEDICAL Co., Ltd.2026-07-24
MedicCO2LON (MedicCO2LON) (K240847)Ide Vision, Ltd.2024-10-30
EVA5 Insufflator (K230474)Palliare , Ltd.2023-03-24
END 200 Endoscopic Tubeset (K202922)Palliare , Ltd.2021-07-08
CO2mbiLED (K201096)Karl Storz Endoscopy America, Inc.2020-06-23
BAROnova Insufflation System, BAROnova Accessory Kit (K190985)Baronova, Inc.2019-05-14
FUJIFILM Endoscopic CO2 Regulator GW-100 (K180711)Fujifilm Corporation2018-05-25
Nexcore GI Insufflator (K162332)Nexcore Technology, LLC2016-09-29
FUJIFILM ENDOSCOPIC CO2 REGULATOR (K133976)Fujifilm Medical System U.S.A., Inc.2014-09-09
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (K132192)Bracco Diagnostic, Inc.2014-02-14
BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (K123047)Bracco Diagnostic, Inc.2013-08-06
ENDOGATER AVANTAGE CO2 INSUFFLATOR (K113310)Byrne Medical, Inc.2012-06-20
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR (K111648)Bracco Diagnostic, Inc.2011-11-03
INSUFLOW CO2IONSHIELD (K090879)Lexion Medical, LLC2009-07-23
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 (K063786)Olympus Medical Systems Corporation2007-03-05
E-Z-EM ENDOSCOPIC CO2 REGULATOR (K053008)E-Z-Em, Inc.2005-12-27
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 (K030854)E-Z-Em, Inc.2003-04-16
PROTOCO2L INSUFFLATOR MODEL 6400 (K013219)E-Z-Em, Inc.2002-02-19
INSUFFLATOR FILTER TUBING SET (K945970)Xylog Corp.1994-12-15
E-Z-FLATE (K930581)E-Z-Em, Inc.1994-07-01
INSUFFLATION TUBING SET, PHX500-082 (K935059)Phx Technologies Corp.1993-12-22
HIFLO FILTERED INSUFFLATION TUBING (K930508)W. J. Medical Instruments, Inc.1993-06-25
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE (K910716)Richard Wolf Medical Instruments Corp.1991-04-16
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR (K881004)Keymed, Inc.1988-05-12
ENDOSCOPIC MANUAL AIR INSUFFLATOR (K844689)Jayco Pharmaceuticals1985-01-02

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