Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FSP · 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) |
|---|---|---|---|---|---|
| K895248 | IMS5000 ILLUMINATED LOUPES | Luxtec Corp. | 1989-09-15 | 25 | 0 |
| K891895 | SURGICAL LOUPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K864386 | LUXTEC LOUPES FOR SURGICAL VISION | Luxtec Corp. | 1986-11-17 | 12 | 0 |
| K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | Keeler Instruments, Inc. | 1986-05-23 | 17 | 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