Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hancock Laboratories, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
46 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801885 | HANCOCK * OBTURATORS | Hancock Laboratories, Inc. | 1980-09-09 | 33 | 0 |
| K800703 | MODIFIED CATHETER PACKAGE | Hancock Laboratories, Inc. | 1980-04-08 | 12 | 0 |
| K800122 | HANCOCK AORTIC PUNCH | Hancock Laboratories, Inc. | 1980-02-01 | 14 | 0 |
| K790534 | MERSILENE SUTURES | Hancock Laboratories, Inc. | 1979-03-26 | 13 | 0 |
| K780568 | DURAN FLEXIBLE RING | Hancock Laboratories, Inc. | 1978-05-26 | 46 | 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