Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micromedical Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
200 daysmedian FDA review time
258 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964646 | VIDEO EYE TRAKKER | Micromedical Technologies, Inc. | 1997-07-15 | 237 | 0 |
| K964325 | VISUALEYES: VIDEO EYE MONITOR | Micromedical Technologies, Inc. | 1997-07-15 | 258 | 0 |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | Micromedical Technologies, Inc. | 1992-10-26 | 178 | 0 |
| K891008 | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | Micromedical Technologies, Inc. | 1989-05-31 | 89 | 0 |
| K863424 | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE | Micromedical Technologies, Inc. | 1987-03-23 | 200 | 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