Polynovo Biomaterials Pty, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Polynovo Biomaterials Pty, Ltd.” (first 2014, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 132 days. Since 2017 the median was 63 days, against 216 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 167 |
| 2015 | 1 | 447 |
| 2016 | 0 | — |
| 2017 | 1 | 25 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 97 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 127 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Polynovo Biomaterials Pty, Ltd. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 216 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QSZ | Absorbable Synthetic Wound Dressing | 5 | 5 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 1 | 1 |
Review panels
Most recent Polynovo Biomaterials Pty, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251567 | NovoSorb BTM | QSZ | 2025-06-20 | 29 |
| K242149 | NovoSorb® MTX | QSZ | 2025-03-05 | 225 |
| K221686 | NovoSorb Matrix | QSZ | 2022-09-15 | 97 |
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) | QSZ | 2017-08-11 | 25 |
| K142879 | BTM Wound Dressing | QSZ | 2015-12-23 | 447 |
| K132936 | NOVOPORE DRESSING | OMP | 2014-03-04 | 167 |
Recalls
openFDA lists no recalls under a recalling firm named Polynovo Biomaterials Pty, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Polynovo Biomaterials Pty, Ltd. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04090424: Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns (Active not recruiting, started 2021-09-21)
- NCT02905435: Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries (Completed, started 2016-11-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polynovo Biomaterials Pty, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Polynovo Biomaterials Pty, Ltd.” (first 2014, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Polynovo Biomaterials Pty, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polynovo Biomaterials Pty, Ltd. is 132 days. Since 2017: 63 days, versus 216 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Polynovo Biomaterials Pty, Ltd.?
The most frequent FDA product codes under this applicant name are QSZ (Absorbable Synthetic Wound Dressing, 5); OMP (Negative Pressure Wound Therapy Powered Suction Pump, 1).
Next steps
- See all 6 Polynovo Biomaterials Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QSZ, Polynovo Biomaterials Pty, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.