ShenB Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “ShenB Co., Ltd.” (first 2020, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 123 days. Since 2017 the median was 123 days, against 122 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 |
|---|---|---|
| 2020 | 1 | 172 |
| 2021 | 3 | 187 |
| 2022 | 1 | 70 |
| 2023 | 2 | 91 |
| 2024 | 1 | 118 |
| 2025 | 2 | 172 |
| 2026 | 1 | 123 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name ShenB Co., Ltd. took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 8 | 8 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent ShenB Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253926 | Diacore | NGX | 2026-04-10 | 123 |
| K251649 | Sunny Plus (Sunny) | NFO | 2025-09-18 | 112 |
| K242241 | Sunny | GEI | 2025-03-19 | 231 |
| K241535 | Vybe RF II | GEI | 2024-09-25 | 118 |
| K232223 | PlaDuo System | GEI | 2023-10-24 | 90 |
| K230968 | VYBE RF Electrosurgical System | GEI | 2023-07-06 | 92 |
| K221363 | AF Laser | PDZ | 2022-07-20 | 70 |
| K211562 | Virtue RF | GEI | 2021-11-23 | 187 |
| K193070 | VIVACE Electrosurgical Device | GEI | 2021-04-26 | 539 |
| K202415 | VirtueRF | GEI | 2021-01-22 | 151 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named ShenB 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 ShenB Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “ShenB Co., Ltd.” (first 2020, latest 2026), across 4 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 ShenB Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name ShenB Co., Ltd. is 123 days. Since 2017: 123 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under ShenB Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 8); NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 1); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 1).
Next steps
- See all 11 ShenB Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, ShenB 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.