Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brimfield Scientific Instruments — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
81 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852042 | BRIMFIELD CANNULATED BLADE HOLDER | Brimfield Scientific Instruments | 1985-06-11 | 33 | 0 |
| K843135 | BRIMFIELD CANNULATED MAGNETIC RETRIEVER | Brimfield Scientific Instruments | 1984-09-26 | 48 | 0 |
| K843136 | BRIMFIELD CANNULATED GRASPING HOOKS | Brimfield Scientific Instruments | 1984-09-25 | 47 | 0 |
| K841731 | BRIMFIELD FIBEROPTIC LIGHT SCOURCE | Brimfield Scientific Instruments | 1984-07-16 | 81 | 0 |
| K832147 | CIRCUT 1 | Brimfield Scientific Instruments | 1983-07-26 | 26 | 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