Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EFL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
24 daysmedian FDA review time
25 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890243 | DRESSING FORCEPS | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K821778 | BEACH DRESSING PLIER | Pacific Dental Corp. | 1982-07-06 | 19 | 0 |
| K821282 | THUMB DRESSING FORCEPS 5 | Conphar, Inc. | 1982-05-28 | 25 | 0 |
| K821284 | ADSON FORCEPS 4 3/4 | Conphar, Inc. | 1982-05-28 | 24 | 0 |
| K821285 | SPLINTER FORCEPS 4 1/2 | Conphar, Inc. | 1982-05-28 | 24 | 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