Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GCQ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
95 daysmedian FDA review time
386 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920979 | CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) | Codman & Shurtleff, Inc. | 1993-03-23 | 386 | 0 |
| K900894 | MEDILASE SERIES 2100 ENDOSCOPE | Medical Laser, Inc. | 1990-06-22 | 115 | 0 |
| K871978 | CODMAN FLEXIBLE ENDOSCOPE | Codman & Shurtleff, Inc. | 1987-08-25 | 95 | 0 |
| K864960 | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. | Cooper Lasersonics, Inc. | 1987-02-10 | 50 | 0 |
| K860771 | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE | Van-Tec, Inc. | 1986-04-23 | 51 | 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