Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mediana Co., Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
250 daysmedian FDA review time
381 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020-10-09 | 228 | 0 |
| K170497 | V10 | Mediana Co., Ltd. | 2017-12-15 | 301 | 0 |
| K160358 | DT-100 | Mediana Co., Ltd. | 2017-02-24 | 381 | 0 |
| K152659 | V10 | Mediana Co., Ltd. | 2016-08-25 | 343 | 0 |
| K112190 | PATIENT MONITOR | Mediana Co., Ltd. | 2011-11-09 | 103 | 0 |
| K110612 | FM20 | Mediana Co., Ltd. | 2011-11-08 | 250 | 0 |
| K110630 | F10 | Mediana Co., Ltd. | 2011-06-24 | 113 | 0 |
| K100225 | PULSE OXIMETER MODEL P10 | Mediana Co., Ltd. | 2011-02-09 | 379 | 0 |
| K100217 | LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 | Mediana Co., Ltd. | 2010-06-08 | 134 | 0 |
| K051375 | VITAL SIGNS MONITOR | Mediana Co., Ltd. | 2005-07-28 | 63 | 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