Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QAU — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
211 daysmedian FDA review time
686 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261503 | PuraStat GI | 3-D Matrix, Inc. | 2026-08-03 | 89 | 0 |
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. | 2026-06-02 | 246 | 0 |
| K253924 | PuraStat | 3-D Matrix Europe SAS | 2026-01-07 | 30 | 0 |
| K240994 | Nexpowder | Nextbiomedical Co., Ltd. | 2024-11-27 | 230 | 0 |
| K242250 | PuraStat | 3-D Matrix Europe SAS | 2024-10-22 | 83 | 0 |
| K234131 | Resolv Endoscopic Hemostat System | Hemostasis, LLC | 2024-07-26 | 211 | 0 |
| K222481 | PuraStat | 3-D Matrix, Inc. | 2023-02-28 | 195 | 0 |
| K202929 | Nexpowder | Nextbiomedical Co., Ltd. | 2022-09-16 | 717 | 0 |
| K210098 | PuraStat-GI | 3-D Matrix, Inc. | 2021-06-25 | 162 | 0 |
| K190677 | EndoClot | Endoclot Plus Co., Ltd. | 2021-01-29 | 686 | 0 |
| K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2020-06-10 | 58 | 3 |
| DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018-05-07 | 424 | 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