Medcaptain Life Science Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medcaptain Life Science Co., Ltd.” (first 2021, latest 2023), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 232 days. Since 2017 the median was 232 days, against 186 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 |
|---|---|---|
| 2021 | 3 | 231 |
| 2022 | 1 | 232 |
| 2023 | 1 | 277 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medcaptain Life Science Co., Ltd. took a median 232 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Medcaptain Life Science Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230528 | Extension Set | FPA | 2023-12-01 | 277 |
| K213004 | Needle Free Connector | FPA | 2022-05-10 | 232 |
| K202578 | KardiFlex NC Coronary Dilatation Catheter | LOX | 2021-05-06 | 240 |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | LOX | 2021-04-29 | 231 |
| K202748 | Enteral Feeding Catheter | KNT | 2021-04-09 | 200 |
Recalls
openFDA lists no recalls under a recalling firm named Medcaptain Life Science 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medcaptain Life Science Co., Ltd. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medcaptain Life Science Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Medcaptain Life Science Co., Ltd.” (first 2021, latest 2023), across 3 product codes in 3 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 Medcaptain Life Science Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcaptain Life Science Co., Ltd. is 232 days. Since 2017: 232 days, versus 186 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medcaptain Life Science Co., Ltd.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 2); KNT (Tubes, Gastrointestinal (And Accessories), 1).
Next steps
- See all 5 Medcaptain Life Science Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Medcaptain Life Science 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.