Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Z-Medica, LLC · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
471 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220971 | QuikClot Control+ Hemostatic Dressing | Z-Medica, LLC | 2022-12-14 | 254 | 0 |
| K200167 | QuikClot Control+ | Z-Medica, LLC | 2020-04-23 | 91 | 0 |
| K181641 | QuikClot Radial | Z-Medica, LLC | 2018-12-24 | 186 | 0 |
| DEN160012 | D2 Dressing | Z-Medica, LLC | 2017-06-30 | 471 | 0 |
| K140757 | D2 HEMOSTANTIC DRESSING | Z-Medica, LLC | 2014-07-17 | 113 | 0 |
| K123387 | QUIKCLOT HEMOSTATIC DRESSING | Z-Medica, LLC | 2013-04-12 | 161 | 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