Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
W. J. Medical Instruments, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935947 | HI-TOPS ELECTRODES 14-8000 | W. J. Medical Instruments, Inc. | 1994-02-28 | 77 | 0 |
| K930511 | STEALTH SURGICAL IRRIGATOR ASPIRATOR | W. J. Medical Instruments, Inc. | 1993-06-25 | 144 | 2 |
| K930508 | HIFLO FILTERED INSUFFLATION TUBING | W. J. Medical Instruments, Inc. | 1993-06-25 | 144 | 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