Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endochoice, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
234 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox Processor | Endochoice, Inc. | 2016-08-01 | 181 | 0 |
| K161482 | EndoChoice Water Bottle Cap Irrigation System | Endochoice, Inc. | 2016-06-27 | 27 | 0 |
| K161167 | Seal Single-Use Biopsy Valve | Endochoice, Inc. | 2016-05-26 | 30 | 0 |
| K160403 | SmartStart Air/Water and Suction Valves | Endochoice, Inc. | 2016-05-19 | 97 | 0 |
| K153588 | EndoChoice Water Bottle Cap System | Endochoice, Inc. | 2016-02-24 | 70 | 0 |
| K151475 | EndoChoice Select Injection Needle | Endochoice, Inc. | 2016-02-08 | 251 | 0 |
| K152182 | Fuse Gastroscopy System | Endochoice, Inc. | 2015-12-10 | 127 | 0 |
| K152580 | rescuenet | Endochoice, Inc. | 2015-11-03 | 54 | 0 |
| K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Endochoice, Inc. | 2015-01-20 | 167 | 0 |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | Endochoice, Inc. | 2014-10-17 | 234 | 0 |
| K141598 | FUSE COLONOSCOPY SYSTEM | Endochoice, Inc. | 2014-09-30 | 109 | 1 |
| K140760 | BONASTENT BILIARY | Endochoice, Inc. | 2014-06-16 | 82 | 0 |
| K133734 | SEAL SINGLE-USE BIOPSY VALVE | Endochoice, Inc. | 2014-03-19 | 100 | 0 |
| K132839 | FUSE 1C COLONOSCOPY SYSTEM | Endochoice, Inc. | 2014-02-06 | 149 | 0 |
| K132065 | INJECTION NEEDLE | Endochoice, Inc. | 2014-01-17 | 198 | 0 |
| K133747 | ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM | Endochoice, Inc. | 2014-01-08 | 30 | 0 |
| K132776 | SEAL BIOPSY VALVE - REUSABLE | Endochoice, Inc. | 2013-12-20 | 106 | 0 |
| K131991 | ENDOCHOICE HOT BIOPSY FORCEPS | Endochoice, Inc. | 2013-10-15 | 109 | 0 |
| K131422 | PEERSCOPE SYSTEM | Endochoice, Inc. | 2013-10-10 | 147 | 0 |
| K132535 | AUTOBAND LIGATOR | Endochoice, Inc. | 2013-08-23 | 10 | 0 |
| K123223 | EC SINGLE USE, POLYPECTOMY SNARE | Endochoice, Inc. | 2013-01-10 | 87 | 0 |
| K120862 | WATER BOTTLE CAP IRRIGATON SYSTEM | Endochoice, Inc. | 2012-11-27 | 250 | 0 |
| K112576 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | Endochoice, Inc. | 2012-01-25 | 141 | 0 |
| K111821 | BIOPSY VALVE | Endochoice, Inc. | 2011-07-28 | 30 | 0 |
| K101298 | ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL | Endochoice, Inc. | 2010-08-05 | 87 | 0 |
| K093003 | BONASTENT BILIARY | Endochoice, Inc. | 2010-03-24 | 177 | 0 |
| K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEA | Endochoice, Inc. | 2010-02-22 | 222 | 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