MEDA Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “MEDA Co., Ltd.” (first 2007, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 136 |
| 2013 | 1 | 373 |
| 2014 | 0 | — |
| 2015 | 1 | 92 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 238 |
| 2020 | 0 | — |
| 2021 | 1 | 56 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name MEDA Co., Ltd. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 7 |
Review panels
- Radiology (7)
Most recent MEDA Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213070 | MD-320W Ultrasound Biomicroscope | IYO | 2021-11-18 | 56 |
| K182460 | MD-6000P Bladder Scanner | IYO | 2019-05-06 | 238 |
| K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | IYO | 2015-11-17 | 92 |
| K121243 | ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER | IYO | 2013-05-03 | 373 |
| K113304 | BLADDER SCANNER | IYO | 2012-03-23 | 136 |
| K063472 | ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 | IYO | 2007-01-31 | 77 |
| K063433 | ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 | IYO | 2007-01-29 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named MEDA Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Meda Stat Diagnostics, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under MEDA Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “MEDA Co., Ltd.” (first 2007, latest 2021), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by MEDA Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name MEDA Co., Ltd. is 92 days.
Which FDA product codes appear under MEDA Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 7).
Next steps
- See all 7 MEDA Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYO, MEDA Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.