Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gabriel Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
163 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960173 | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | Gabriel Medical, Inc. | 1996-06-27 | 163 | 0 |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | Gabriel Medical, Inc. | 1995-02-07 | 113 | 0 |
| K945297 | INFRA VISION IMAGING SYSTEM | Gabriel Medical, Inc. | 1994-12-20 | 50 | 1 |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | Gabriel Medical, Inc. | 1994-05-02 | 119 | 0 |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | Gabriel Medical, Inc. | 1990-05-09 | 44 | 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