Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cogent Light Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
221 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | Cogent Light Technologies, Inc. | 2000-07-17 | 45 | 0 |
| K983714 | SOLARTEC SOURCE 270, MODEL # 90123 | Cogent Light Technologies, Inc. | 1998-12-23 | 63 | 0 |
| K971057 | COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM | Cogent Light Technologies, Inc. | 1997-03-28 | 4 | 0 |
| K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | Cogent Light Technologies, Inc. | 1994-03-10 | 80 | 0 |
| K933405 | COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE | Cogent Light Technologies, Inc. | 1994-02-18 | 221 | 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