Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Byrne Medical, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
189 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | Byrne Medical, Inc. | 2012-06-20 | 225 | 0 |
| K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | Byrne Medical, Inc. | 2012-04-27 | 189 | 0 |
| K102855 | UNIVERSAL IRRIGATION SOLUTION HYBRID | Byrne Medical, Inc. | 2010-11-19 | 51 | 0 |
| K102581 | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 | Byrne Medical, Inc. | 2010-11-08 | 61 | 0 |
| K102409 | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 | Byrne Medical, Inc. | 2010-11-04 | 72 | 0 |
| K093665 | ENDO SMARTCAP | Byrne Medical, Inc. | 2009-12-15 | 20 | 0 |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | Byrne Medical, Inc. | 2009-11-30 | 139 | 0 |
| K092429 | ENDOGATOR | Byrne Medical, Inc. | 2009-11-19 | 104 | 0 |
| K090851 | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDO | Byrne Medical, Inc. | 2009-07-02 | 94 | 0 |
| K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | Byrne Medical, Inc. | 2006-04-19 | 12 | 0 |
| K033695 | IRRIGATION CHANNEL TUBING, MODEL 100135 | Byrne Medical, Inc. | 2003-12-23 | 28 | 0 |
| K031773 | ENDO GATOR SYSTEM | Byrne Medical, Inc. | 2003-06-24 | 15 | 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