Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baisheng Medical Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
192 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | 2025-08-13 | 146 | 0 |
| K251235 | Electrosurgical Pads | Baisheng Medical Co., Ltd. | 2025-06-19 | 58 | 0 |
| K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1 | Baisheng Medical Co., Ltd. | 2024-01-08 | 56 | 0 |
| K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS- | Baisheng Medical Co., Ltd. | 2022-11-23 | 154 | 0 |
| K162034 | OBS Electrosurgical Generator (Model: OBS-350A) | Baisheng Medical Co., Ltd. | 2017-01-30 | 192 | 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