Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precision 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) |
|---|---|---|---|---|---|
| K864520 | BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON | Precision Instruments, Inc. | 1987-01-20 | 64 | 0 |
| K860648 | BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA | Precision Instruments, Inc. | 1986-03-25 | 33 | 0 |
| K843048 | RING SUPPORTED TREPHINE FOR CORNEA TRANS | Precision Instruments, Inc. | 1984-10-05 | 63 | 0 |
| K801585 | HESSBURG-BFRRON TREPHINE | Precision Instruments, Inc. | 1980-10-03 | 84 | 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