Berwick Medical Products, Inc.: FDA clearances and approvals
Berwick Medical Products, Inc. has 5 FDA 510(k) clearances (first 1983, latest 1985), across 5 product codes in 2 review panels. Median 510(k) review time: 57 days.
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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 1 | 1 |
| DJY | Ion-Exchange Chromatography | 1 | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | 1 |
| KEA | Resins, Ion-Exchange | 1 | 1 |
Review panels
Most recent Berwick Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850800 | DROPSTIRS - PLASTIC DISPOSABLE PIPET | JQW | 1985-04-02 | 34 |
| K842018 | ISO-SEP SYSTEM | CEX | 1984-09-28 | 133 |
| K831434 | ISO-SEP SYSTEM | CDP | 1983-06-30 | 57 |
| K831289 | PREFILLED IEC COLUMNS | DJY | 1983-06-16 | 57 |
| K830918 | I.E.C COLUMN | KEA | 1983-04-27 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Berwick Medical Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Berwick Medical Products, Inc. have?
Berwick Medical Products, Inc. has 5 FDA 510(k) clearances (first 1983, latest 1985), across 5 product codes in 2 review panels.
How long does FDA take to clear Berwick Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Berwick Medical Products, Inc.'s cleared 510(k)s is 57 days.
What devices does Berwick Medical Products, Inc. make?
Its most frequent FDA product codes are CDP (Radioimmunoassay, Total Triiodothyronine, 1); CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes, 1); DJY (Ion-Exchange Chromatography, 1).
Has Berwick Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Berwick Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 5 Berwick Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDP, Berwick Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.