Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ShenB Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
231 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253926 | Diacore | ShenB Co., Ltd. | 2026-04-10 | 123 | 0 |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd. | 2025-09-18 | 112 | 0 |
| K242241 | Sunny | ShenB Co., Ltd. | 2025-03-19 | 231 | 0 |
| K241535 | Vybe RF II | ShenB Co., Ltd. | 2024-09-25 | 118 | 0 |
| K232223 | PlaDuo System | ShenB Co., Ltd. | 2023-10-24 | 90 | 0 |
| K230968 | VYBE RF Electrosurgical System | ShenB Co., Ltd. | 2023-07-06 | 92 | 0 |
| K221363 | AF Laser | ShenB Co., Ltd. | 2022-07-20 | 70 | 0 |
| K211562 | Virtue RF | ShenB Co., Ltd. | 2021-11-23 | 187 | 0 |
| K193070 | VIVACE Electrosurgical Device | ShenB Co., Ltd. | 2021-04-26 | 539 | 0 |
| K202415 | VirtueRF | ShenB Co., Ltd. | 2021-01-22 | 151 | 0 |
| K201735 | PlaDuo System | ShenB Co., Ltd. | 2020-12-14 | 172 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda