Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MEDA Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
373 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213070 | MD-320W Ultrasound Biomicroscope | MEDA Co., Ltd. | 2021-11-18 | 56 | 0 |
| K182460 | MD-6000P Bladder Scanner | MEDA Co., Ltd. | 2019-05-06 | 238 | 0 |
| K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | MEDA Co., Ltd. | 2015-11-17 | 92 | 0 |
| K121243 | ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER | MEDA Co., Ltd. | 2013-05-03 | 373 | 0 |
| K113304 | BLADDER SCANNER | MEDA Co., Ltd. | 2012-03-23 | 136 | 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