Promedical Products Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Promedical Products Co., Ltd.” (first 2004, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
Review panels
- General Hospital (6)
Most recent Promedical Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091097 | PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 | FYA | 2009-05-27 | 41 |
| K080629 | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS | KKX | 2008-10-20 | 229 |
| K080627 | PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A | FYA | 2008-04-24 | 50 |
| K042131 | PROMEDICAL SURGICAL DRAPES | KKX | 2004-12-10 | 123 |
| K042111 | PROMEDICAL SURGICAL GOWNS | FYA | 2004-12-10 | 127 |
| K042137 | PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS | KKX | 2004-10-05 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Promedical Products 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.
- Promedical , Ltd. (5 510(k)s)
- Promedical Industries, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Promedical Products Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Promedical Products Co., Ltd.” (first 2004, latest 2009), across 2 product codes 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 Promedical Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Promedical Products Co., Ltd. is 90 days.
Which FDA product codes appear under Promedical Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 3); KKX (Drape, Surgical, Antimicrobial, 3).
Next steps
- See all 6 Promedical Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FYA, Promedical Products 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.