FMD Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “FMD Co., Ltd.” (first 2003, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 118 days, against 135 days for all cleared 510(k)s in the same product codes. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 311 |
| 2023 | 0 | — |
| 2024 | 1 | 118 |
| 2025 | 0 | — |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name FMD Co., Ltd. took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 3 | 3 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 2 | 2 |
Review panels
Most recent FMD Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | DQX | 2026-03-20 | 30 |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | DQX | 2024-06-13 | 118 |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | DQX | 2022-05-27 | 311 |
| K042561 | TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | LNS | 2004-10-12 | 21 |
| K030346 | TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | LNS | 2003-05-02 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named FMD 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under FMD Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “FMD Co., Ltd.” (first 2003, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by FMD Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name FMD Co., Ltd. is 88 days. Since 2017: 118 days, versus 135 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under FMD Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 3); LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 2).
Next steps
- See all 5 FMD Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQX, FMD 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.