Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precept, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
87 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771409 | DISP. SURGICAL FACE MASK | Precept, Inc. | 1977-10-27 | 87 | 0 |
| K770463 | MASK, SURGICAL, FACE, DISPOSABLE | Precept, Inc. | 1977-03-23 | 14 | 0 |
| K770391 | COVER, ARMBOARD, DISPOSABLE | Precept, Inc. | 1977-03-07 | 7 | 0 |
| K770021 | MASK, FACE, SURGICAL | Precept, Inc. | 1977-01-17 | 11 | 0 |
| K760360 | SHIRT, MITTEN CUFF INFANT | Precept, Inc. | 1976-10-20 | 79 | 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