FCX · Class II · 21 CFR 876.1500

FDA Product Code FCX: Insufflator, Automatic Carbon-dioxide For Endoscope

Leading manufacturers include E-Z-Em, Inc., Bracco Diagnostic, Inc. and Palliare , Ltd..

25
Total
25
Cleared
128d
Avg days
1985
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 29d recently vs 132d historically

FDA 510(k) Cleared Insufflator, Automatic Carbon-dioxide For Endoscope Devices (Product Code FCX)

25 devices
1–24 of 25
Cleared Jul 24, 2026
VS-370CF, VS-370CT
K262152
VISION MEDICAL Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 30, 2024
MedicCO2LON (MedicCO2LON)
K240847
Ide Vision, Ltd.
Gastroenterology & Urology · 217d
Cleared Mar 24, 2023
EVA5 Insufflator
K230474
Palliare , Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 08, 2021
END 200 Endoscopic Tubeset
K202922
Palliare , Ltd.
Gastroenterology & Urology · 282d
Cleared Jun 23, 2020
CO2mbiLED
K201096
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 60d
Cleared May 14, 2019
BAROnova Insufflation System, BAROnova Accessory Kit
K190985
Baronova, Inc.
Gastroenterology & Urology · 29d
Cleared May 25, 2018
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711
Fujifilm Corporation
Gastroenterology & Urology · 67d
Cleared Sep 29, 2016
Nexcore GI Insufflator
K162332
Nexcore Technology, LLC
Gastroenterology & Urology · 41d
Cleared Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 257d
Cleared Feb 14, 2014
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
K132192
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 214d
Cleared Aug 06, 2013
BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET
K123047
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 312d
Cleared Jun 20, 2012
ENDOGATER AVANTAGE CO2 INSUFFLATOR
K113310
Byrne Medical, Inc.
Gastroenterology & Urology · 225d
Cleared Nov 03, 2011
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
K111648
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 143d
Cleared Jul 23, 2009
INSUFLOW CO2IONSHIELD
K090879
Lexion Medical, LLC
Gastroenterology & Urology · 114d
Cleared Mar 05, 2007
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786
Olympus Medical Systems Corporation
Gastroenterology & Urology · 74d
Cleared Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008
E-Z-Em, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854
E-Z-Em, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219
E-Z-Em, Inc.
Gastroenterology & Urology · 146d
Cleared Dec 15, 1994
INSUFFLATOR FILTER TUBING SET
K945970
Xylog Corp.
Gastroenterology & Urology · 7d
Cleared Jul 01, 1994
E-Z-FLATE
K930581
E-Z-Em, Inc.
Gastroenterology & Urology · 512d
Cleared Dec 22, 1993
INSUFFLATION TUBING SET, PHX500-082
K935059
Phx Technologies Corp.
Gastroenterology & Urology · 62d
Cleared Jun 25, 1993
HIFLO FILTERED INSUFFLATION TUBING
K930508
W. J. Medical Instruments, Inc.
Gastroenterology & Urology · 144d
Cleared Apr 16, 1991
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
K910716
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 55d
Cleared May 12, 1988
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
K881004
Keymed, Inc.
Gastroenterology & Urology · 64d

About Product Code FCX - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code FCX since 1985, with 25 receiving FDA clearance (average review time: 128 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - FCX Product Code

Recent submissions under FCX have taken an average of 29 days to reach a decision - down from 132 days historically, suggesting improved FDA processing for this classification.

FCX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →