Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FQP · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
77 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001223 | ACULUX, MODEL AX3001, AX3002 | Aculux | 2000-06-23 | 67 | 0 |
| K993314 | SYNTHES LIGHT GUIDE | Synthes (Usa) | 1999-12-06 | 63 | 0 |
| K781581 | SURGICAL LIGHT 22 SERIES | American Sterilizer Co. | 1978-10-17 | 32 | 0 |
| K770812 | HANDLES, LIGHT, SURGICAL, STEOILE | Sybron Corp. | 1977-05-23 | 20 | 0 |
| K761018 | SURGICAL LIGHT - CHALLENGE 22 SERIES | Amsco Co. | 1977-01-26 | 77 | 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