Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precision Medical Instruments, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852758 | INFUSION CANNULAM | Precision Medical Instruments, Inc. | 1985-08-01 | 34 | 0 |
| K832560 | ASPIRATING HANDLE W/BACKFLUSHING CAPAB | Precision Medical Instruments, Inc. | 1984-01-04 | 156 | 0 |
| K830037 | EXTENSION HANDLE FOR ACUTOME PROBE | Precision Medical Instruments, Inc. | 1983-04-06 | 89 | 0 |
| K791212 | VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG | Precision Medical Instruments, Inc. | 1979-08-10 | 38 | 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