Baisheng Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Baisheng Medical Co., Ltd.” (first 2017, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 146 days. Since 2017 the median was 146 days, against 113 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 |
|---|---|---|
| 2017 | 1 | 192 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 154 |
| 2023 | 0 | — |
| 2024 | 1 | 56 |
| 2025 | 2 | 102 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Baisheng Medical Co., Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
Most recent Baisheng Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250841 | Electrotherapy Electrodes | GXY | 2025-08-13 | 146 |
| K251235 | Electrosurgical Pads | GEI | 2025-06-19 | 58 |
| K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 | GEI | 2024-01-08 | 56 |
| K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) | GEI | 2022-11-23 | 154 |
| K162034 | OBS Electrosurgical Generator (Model: OBS-350A) | GEI | 2017-01-30 | 192 |
Recalls
openFDA lists no recalls under a recalling firm named Baisheng Medical 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 Baisheng Medical Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Baisheng Medical Co., Ltd.” (first 2017, latest 2025), 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 Baisheng Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baisheng Medical Co., Ltd. is 146 days. Since 2017: 146 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Baisheng Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 5 Baisheng Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Baisheng Medical 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.