Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micromed S.P.A. — 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) |
|---|---|---|---|---|---|
| K211974 | LED PHOTIC System | Micromed S.P.A. | 2021-09-23 | 90 | 0 |
| K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018-06-18 | 87 | 0 |
| K171384 | Micromed BRAIN QUICK system | Micromed S.P.A. | 2018-02-01 | 266 | 1 |
| K071782 | MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES | Micromed S.P.A. | 2008-01-10 | 192 | 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