Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Instruments Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
261 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012614 | KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; | Medical Instruments Technology, Inc. | 2002-05-01 | 261 | 0 |
| K012640 | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTRO | Medical Instruments Technology, Inc. | 2002-02-28 | 199 | 1 |
| K012624 | REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVE | Medical Instruments Technology, Inc. | 2001-11-08 | 87 | 0 |
| K012632 | TOURNIQUET CUFF; PNEUMATIC TOURNIQUET | Medical Instruments Technology, Inc. | 2001-10-26 | 74 | 0 |
| K884611 | THE ORTHORANGER II ELECTRONIC GONIOMETER | Medical Instruments Technology, Inc. | 1989-01-31 | 88 | 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