Halifax Biomedical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Halifax Biomedical, Inc.” (first 2009, latest 2018), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 72 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 | 1 | 28 |
| 2013 | 0 | — |
| 2014 | 1 | 72 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 16 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Halifax Biomedical, Inc. took a median 16 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 2 | 2 |
| NEU | Marker, Radiographic, Implantable | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
Most recent Halifax Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182880 | Halifax Imaging Kit | KPR | 2018-10-31 | 16 |
| K133966 | MODEL-BASED RSA SOFTWARE | LLZ | 2014-03-06 | 72 |
| K121345 | SR SUITE 1.0 | KPR | 2012-06-01 | 28 |
| K103417 | HALIFAX BIOMEDICAL TANATLUM BEAD SET | NEU | 2011-06-28 | 218 |
| K090581 | TANTALUM BEAD SET, MODEL P003175 | NEU | 2009-08-21 | 171 |
Recalls
openFDA lists no recalls under a recalling firm named Halifax 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Halifax Biomedical, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Halifax Biomedical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Halifax Biomedical, Inc.” (first 2009, latest 2018), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Halifax Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Halifax Biomedical, Inc. is 72 days.
Which FDA product codes appear under Halifax Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 2); NEU (Marker, Radiographic, Implantable, 2); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 5 Halifax Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Halifax 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, 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.