Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Polynovo Biomaterials Pty, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
447 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251567 | NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. | 2025-06-20 | 29 | 0 |
| K242149 | NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. | 2025-03-05 | 225 | 0 |
| K221686 | NovoSorb Matrix | Polynovo Biomaterials Pty, Ltd. | 2022-09-15 | 97 | 0 |
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound | Polynovo Biomaterials Pty, Ltd. | 2017-08-11 | 25 | 0 |
| K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015-12-23 | 447 | 0 |
| K132936 | NOVOPORE DRESSING | Polynovo Biomaterials Pty, Ltd. | 2014-03-04 | 167 | 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