Mediana Co., Ltd.: FDA clearances and approvals
Mediana Co., Ltd. has 10 FDA 510(k) clearances (first 2005, latest 2020), across 6 product codes in 4 review panels. Median 510(k) review time: 239 days. Since 2017 its median was 301 days, against 190 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Mediana Co., Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 343 |
| 2017 | 2 | 341 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 228 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Mediana Co., Ltd.'s cleared 510(k)s took a median 301 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 1 |
Review panels
Most recent Mediana Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200434 | V20, V20a, AVSM3 SNF | DXN | 2020-10-09 | 228 |
| K170497 | V10 | DXN | 2017-12-15 | 301 |
| K160358 | DT-100 | FLL | 2017-02-24 | 381 |
| K152659 | V10 | DXN | 2016-08-25 | 343 |
| K112190 | PATIENT MONITOR | MHX | 2011-11-09 | 103 |
| K110612 | FM20 | HGM | 2011-11-08 | 250 |
| K110630 | F10 | KNG | 2011-06-24 | 113 |
| K100225 | PULSE OXIMETER MODEL P10 | DQA | 2011-02-09 | 379 |
| K100217 | LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 | MHX | 2010-06-08 | 134 |
| K051375 | VITAL SIGNS MONITOR | DXN | 2005-07-28 | 63 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2021-05-17.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Mediana Co., Ltd. have?
Mediana Co., Ltd. has 10 FDA 510(k) clearances (first 2005, latest 2020), across 6 product codes in 4 review panels.
How long does FDA take to clear Mediana Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Mediana Co., Ltd.'s cleared 510(k)s is 239 days. Since 2017: 301 days, versus 190 days for all cleared 510(k)s in the same product codes.
What devices does Mediana Co., Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 2); DQA (Oximeter, 1).
Has Mediana Co., Ltd. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Mediana Co., Ltd; the most recent began 2021-05-17. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Mediana Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Mediana Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.