Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KAD · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
107 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841356 | ELEVATOR | Treace Medical, Inc. | 1984-07-18 | 107 | 0 |
| K822190 | ENT ELEVATORS | Kelleher Corp. | 1982-08-16 | 24 | 0 |
| K822270 | VARIOUS TYPES OF ENT ELEVATORS | Kelleher Corp. | 1982-08-16 | 18 | 0 |
| K772391 | BOIES NASAL FRACTURE ELEVATOR | Edward Weck, Inc. | 1978-01-17 | 21 | 0 |
| K772399 | DINGMAN ZYGOMA ELEVATOR | Edward Weck, Inc. | 1978-01-17 | 21 | 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