Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Iline Microsystems, S.L. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
305 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251564 | microINR System | Iline Microsystems, S.L. | 2025-07-21 | 60 | 0 |
| K243543 | microINR System | Iline Microsystems, S.L. | 2025-02-27 | 104 | 0 |
| K231711 | microINR System | Iline Microsystems, S.L. | 2023-07-11 | 29 | 0 |
| K201185 | microINR System | Iline Microsystems, S.L. | 2020-12-18 | 231 | 0 |
| K180780 | microINR System | Iline Microsystems, S.L. | 2019-01-25 | 305 | 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