Westaim Biomedical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Westaim Biomedical, Inc.” (first 1998, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 116 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 5 | 5 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
Most recent Westaim Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010447 | MODIFICATION TO ACTICOAT FOAM DRESSING | FRO | 2001-03-15 | 30 |
| K002466 | ACTICOAT COMPOSITE DRESSING | FRO | 2001-02-16 | 189 |
| K001519 | ACTICOAT 7 DRESSING | FRO | 2000-10-06 | 143 |
| K992221 | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | FRO | 2000-06-07 | 342 |
| K000051 | ACTICOAT FOAM DRESSING | FRO | 2000-04-05 | 89 |
| K983833 | ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE | KMF | 1998-12-10 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Westaim Biomedical, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- The Westaim Corp. (1 510(k)s)
- Westaim Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Westaim Biomedical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Westaim Biomedical, Inc.” (first 1998, latest 2001), 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 Westaim Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Westaim Biomedical, Inc. is 116 days.
Which FDA product codes appear under Westaim Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 5); KMF (Bandage, Liquid, 1).
Next steps
- See all 6 Westaim Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Westaim Biomedical, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.