Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Berwick Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
133 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850800 | DROPSTIRS - PLASTIC DISPOSABLE PIPET | Berwick Medical Products, Inc. | 1985-04-02 | 34 | 0 |
| K842018 | ISO-SEP SYSTEM | Berwick Medical Products, Inc. | 1984-09-28 | 133 | 0 |
| K831434 | ISO-SEP SYSTEM | Berwick Medical Products, Inc. | 1983-06-30 | 57 | 0 |
| K831289 | PREFILLED IEC COLUMNS | Berwick Medical Products, Inc. | 1983-06-16 | 57 | 0 |
| K830918 | I.E.C COLUMN | Berwick Medical Products, Inc. | 1983-04-27 | 36 | 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