Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meridian AG — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
435 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | 2024-01-25 | 167 | 0 |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 | Meridian AG | 2023-09-12 | 155 | 0 |
| K160677 | MICRORUPTOR 6 | Meridian AG | 2017-05-19 | 435 | 0 |
| K113390 | LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) | Meridian AG | 2012-02-14 | 90 | 0 |
| K072823 | MERILAS 532A | Meridian AG | 2007-12-14 | 73 | 0 |
| K023045 | MICRORUPTER V | Meridian AG | 2002-09-26 | 14 | 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