Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KAL — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
146 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870758 | SMALL MASTOID RETRACTOR | Treace Medical, Inc. | 1987-03-04 | 6 | 0 |
| K833604 | ADJUSTABLE FORK RETRACTOR | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K772381 | RING HANDLE & RETRACTORS | Edward Weck, Inc. | 1978-01-17 | 21 | 0 |
| K772392 | ALLPORT MASTOID RETRACTORS | Edward Weck, Inc. | 1978-01-17 | 21 | 0 |
| K760851 | CONVERSE ALTAR RETRACTOR | V. Mueller O.V. Baxter Healthcare Corp. | 1977-03-10 | 146 | 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