Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FCX — Predicate Candidate Screening
25 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
282 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262152 | VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. | 2026-07-24 | 29 | 0 |
| K240847 | MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. | 2024-10-30 | 217 | 0 |
| K230474 | EVA5 Insufflator | Palliare , Ltd. | 2023-03-24 | 30 | 0 |
| K202922 | END 200 Endoscopic Tubeset | Palliare , Ltd. | 2021-07-08 | 282 | 0 |
| K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020-06-23 | 60 | 0 |
| K190985 | BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. | 2019-05-14 | 29 | 0 |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | Fujifilm Corporation | 2018-05-25 | 67 | 0 |
| K162332 | Nexcore GI Insufflator | Nexcore Technology, LLC | 2016-09-29 | 41 | 0 |
| K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR | Fujifilm Medical System U.S.A., Inc. | 2014-09-09 | 257 | 0 |
| K132192 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR | Bracco Diagnostic, Inc. | 2014-02-14 | 214 | 0 |
| K123047 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE T | Bracco Diagnostic, Inc. | 2013-08-06 | 312 | 0 |
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | Byrne Medical, Inc. | 2012-06-20 | 225 | 0 |
| K111648 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR | Bracco Diagnostic, Inc. | 2011-11-03 | 143 | 0 |
| K090879 | INSUFLOW CO2IONSHIELD | Lexion Medical, LLC | 2009-07-23 | 114 | 0 |
| K063786 | ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 | Olympus Medical Systems Corporation | 2007-03-05 | 74 | 0 |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | E-Z-Em, Inc. | 2005-12-27 | 62 | 0 |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, M | E-Z-Em, Inc. | 2003-04-16 | 29 | 0 |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | E-Z-Em, Inc. | 2002-02-19 | 146 | 0 |
| K945970 | INSUFFLATOR FILTER TUBING SET | Xylog Corp. | 1994-12-15 | 7 | 0 |
| K930581 | E-Z-FLATE | E-Z-Em, Inc. | 1994-07-01 | 512 | 0 |
| K935059 | INSUFFLATION TUBING SET, PHX500-082 | Phx Technologies Corp. | 1993-12-22 | 62 | 0 |
| K930508 | HIFLO FILTERED INSUFFLATION TUBING | W. J. Medical Instruments, Inc. | 1993-06-25 | 144 | 0 |
| K910716 | MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE | Richard Wolf Medical Instruments Corp. | 1991-04-16 | 55 | 0 |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | Keymed, Inc. | 1988-05-12 | 64 | 0 |
| K844689 | ENDOSCOPIC MANUAL AIR INSUFFLATOR | Jayco Pharmaceuticals | 1985-01-02 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda