Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZI · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
53 daysmedian FDA review time
72 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911132 | MULTIPLE, SURGICAL DRAPE PACK | Central Georgia Ancillary Health Systems | 1991-05-06 | 53 | 0 |
| K910468 | STERILE DISPOSABLE DRAPE(S) | E.M. Adams | 1991-03-21 | 45 | 0 |
| K854159 | ELLIPTI-PUNCH | Alcon Laboratories | 1985-11-15 | 35 | 0 |
| K772395 | DAVIS RHYTIDECTOMY | Edward Weck, Inc. | 1978-03-09 | 72 | 0 |
| K772394 | KALRN FACE-LIFE SCISSORS | Edward Weck, Inc. | 1978-03-09 | 72 | 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