Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gamp & Assoc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
214 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952581 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR | Gamp & Assoc. | 1996-01-05 | 214 | 0 |
| K952569 | GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR | Gamp & Assoc. | 1996-01-05 | 214 | 0 |
| K952585 | GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR | Gamp & Assoc. | 1996-01-05 | 214 | 0 |
| K954306 | GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 | 98 | 0 |
| K954308 | GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 | 98 | 0 |
| K954307 | GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE | Gamp & Assoc. | 1995-12-22 | 98 | 0 |
| K952580 | GAMP & ASSOCIATES DISPOSABLE BARE END FIBER | Gamp & Assoc. | 1995-09-01 | 88 | 0 |
| K952586 | GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR | Gamp & Assoc. | 1995-09-01 | 88 | 0 |
| K952584 | GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK | Gamp & Assoc. | 1995-09-01 | 88 | 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