Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FEQ — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
166 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220395 | EndoGator Endoscopy Irrigation Tubing | STERIS Corporation | 2022-03-11 | 28 | 0 |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShi | United States Endoscopy Group, Inc. | 2019-08-01 | 49 | 0 |
| K182258 | AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; Aqu | United States Endoscopy Group, Inc. | 2018-09-21 | 31 | 0 |
| K173650 | AquaShield System CO2- Fujifilm | United States Endoscopy Group, Inc. | 2018-01-05 | 38 | 0 |
| K163424 | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, | United State Endoscopy Group, Inc. | 2017-01-04 | 29 | 0 |
| K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016-08-31 | 29 | 1 |
| K161482 | EndoChoice Water Bottle Cap Irrigation System | Endochoice, Inc. | 2016-06-27 | 27 | 0 |
| K153588 | EndoChoice Water Bottle Cap System | Endochoice, Inc. | 2016-02-24 | 70 | 0 |
| K153362 | AquaShield system CO2, AquaShield system-PENTAX | United States Endoscopy Group, Inc. | 2015-12-16 | 26 | 0 |
| K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Endochoice, Inc. | 2015-01-20 | 167 | 0 |
| K133747 | ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM | Endochoice, Inc. | 2014-01-08 | 30 | 0 |
| K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, E | Erbe USA, Inc. | 2013-12-17 | 144 | 1 |
| K120862 | WATER BOTTLE CAP IRRIGATON SYSTEM | Endochoice, Inc. | 2012-11-27 | 250 | 0 |
| K120123 | AQUASHIELD CO2 SYSTEM | United States Endoscopy Group, Inc. | 2012-03-28 | 71 | 0 |
| K112576 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Endochoice, Inc. | 2012-01-25 | 141 | 0 |
| K103696 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS | Erbe USA, Inc. | 2011-03-22 | 95 | 0 |
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 | Keymed (Medical & Industrial Equipment), Ltd. | 2010-09-13 | 166 | 3 |
| K101146 | WATER BOTTLE CAP SYSTEM | United States Endoscopy Group, Inc. | 2010-07-16 | 84 | 0 |
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | Keymed, Inc. | 2010-04-22 | 31 | 0 |
| K092429 | ENDOGATOR | Byrne Medical, Inc. | 2009-11-19 | 104 | 0 |
| K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 | Keymed (Medical & Industrial Equipment), Ltd. | 2000-05-12 | 50 | 1 |
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