Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Icn Micromedic Systems — 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) |
|---|---|---|---|---|---|
| K884269 | SAMPLE IDENTIFICATION STATION MODEL 38010 | Icn Micromedic Systems | 1989-01-09 | 90 | 0 |
| K883746 | MICROMEDIC FERRITIN IRMA KIT | Icn Micromedic Systems | 1988-10-27 | 56 | 0 |
| K880674 | MICROMEDIC CRACKPOT RIA KIT | Icn Micromedic Systems | 1988-10-06 | 230 | 0 |
| K881102 | MICROMEDIC MORPHINE RIA KIT | Icn Micromedic Systems | 1988-06-24 | 101 | 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