Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Miltex Instrument Co. — 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) |
|---|---|---|---|---|---|
| K922659 | GENERAL SURGERY CLAMP AND NEEDLE HOLDER | Miltex Instrument Co. | 1992-07-21 | 48 | 0 |
| K852141 | STERILE SURGICAL BLADES | Miltex Instrument Co. | 1985-06-13 | 28 | 0 |
| K823536 | INTRALIG | Miltex Instrument Co. | 1982-12-28 | 28 | 0 |
| K812692 | FILES & REAMERS | Miltex Instrument Co. | 1981-10-23 | 31 | 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