Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meridian Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
394 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102375 | LUCIA | Meridian Co., Ltd. | 2011-02-25 | 189 | 0 |
| K081962 | LAPEX BCS | Meridian Co., Ltd. | 2008-12-29 | 173 | 0 |
| K034009 | LAPEX 2000 | Meridian Co., Ltd. | 2005-01-21 | 394 | 0 |
| K023238 | MCPULSE | Meridian Co., Ltd. | 2003-02-19 | 145 | 0 |
| K020360 | ABR-2000 | Meridian Co., Ltd. | 2002-08-29 | 206 | 0 |
| K010897 | MERIDIAN-PORTABLE | Meridian Co., Ltd. | 2001-06-19 | 85 | 0 |
| K001347 | MERIDIAN-II AND MERDIAN-PLUS | Meridian Co., Ltd. | 2000-11-03 | 189 | 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