Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
POD · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
310 daysmedian FDA review time
471 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025-03-18 | 120 | 0 |
| K213198 | Ax-Surgi Surgical Hemostat | Advamedica, Inc. | 2023-01-05 | 463 | 0 |
| K220971 | QuikClot Control+ Hemostatic Dressing | Z-Medica, LLC | 2022-12-14 | 254 | 0 |
| K200167 | QuikClot Control+ | Z-Medica, LLC | 2020-04-23 | 91 | 0 |
| K183190 | NuStat | Beeken Biomedical, LLC | 2019-09-25 | 310 | 0 |
| DEN160012 | D2 Dressing | Z-Medica, LLC | 2017-06-30 | 471 | 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