Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QSZ — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
118 daysmedian FDA review time
279 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-04-16 | 101 | 0 |
| K251567 | NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. | 2025-06-20 | 29 | 0 |
| K242149 | NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. | 2025-03-05 | 225 | 0 |
| K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024-07-05 | 25 | 0 |
| K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023-12-18 | 95 | 0 |
| K223725 | Restrata® MiniMatrix | Acera Surgical, Inc. | 2023-05-18 | 156 | 0 |
| K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022-11-18 | 119 | 0 |
| K221686 | NovoSorb Matrix | Polynovo Biomaterials Pty, Ltd. | 2022-09-15 | 97 | 0 |
| K193583 | Restrata® | Acera Surgical, Inc. | 2020-09-25 | 277 | 0 |
| K173544 | Phoenix Wound Matrix | Nanofiber Solutions, Inc. | 2018-03-02 | 106 | 0 |
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound | Polynovo Biomaterials Pty, Ltd. | 2017-08-11 | 25 | 0 |
| K170213 | SupraSDRM Biodegradable Matrix Wound Dressing | Polymedics Innovations, GmbH | 2017-06-28 | 155 | 0 |
| K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017-04-26 | 85 | 0 |
| K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Woun | Engineered Tissue Solutions, LLC | 2016-09-15 | 153 | 0 |
| K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015-12-23 | 447 | 0 |
| K132397 | GORE BIO-A WOUND MATRIX | W. L. Gore & Associates, Inc. | 2014-05-07 | 279 | 0 |
| K090160 | SUPRATHEL WOUND AND BURN DRESSING | Polymedics Innovations, GmbH | 2009-05-20 | 118 | 0 |
| K073251 | HYALOMATRIX PA | Fidia Advanced Biopolymers Srl | 2007-12-14 | 25 | 0 |
| K031684 | TOPKIN WOUND DRESSING | Biomet Merck GmbH | 2003-10-30 | 153 | 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