Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FSR · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110528 | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | Integra LifeSciences Corporation | 2011-05-11 | 76 | 0 |
| K031549 | SOLID STATE LAMP [LED] HEADLIGHT | Welch Allyn, Inc. | 2003-08-11 | 87 | 0 |
| K031548 | LED HEADLIGHT | Welch Allyn, Inc. | 2003-08-11 | 87 | 0 |
| K994362 | HEADLAMP HL2000. | Angiolaz, Inc. | 2000-05-11 | 136 | 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