Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FSD · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
120 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892379 | THE POUCH GROIN & ABDOMINAL STRESS AID | Kuhn Industries | 1989-07-20 | 105 | 0 |
| K822817 | DOCE ALL-IN-THE-EAR AID | Fidelty Hearing Instruments, Inc. | 1983-01-18 | 120 | 0 |
| K810379 | EARETTE HEARING AID SEARS #8054 | Oticon Corp. | 1981-03-04 | 19 | 0 |
| K770162 | MATERNITY SUPPORTER | R.G. Moore | 1977-02-09 | 16 | 0 |
| K760772 | DISPOSABLE ABDOMINAL BINDER | Tecnol New Jersey Wound Care, Inc. | 1976-11-03 | 30 | 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