Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
345 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2024-02-16 | 267 | 0 |
| K203622 | Medical Gloves | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021-08-20 | 252 | 0 |
| K201639 | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021-05-27 | 345 | 0 |
| K202844 | Medical Surgical Gowns | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021-01-06 | 103 | 0 |
| K202029 | Medical Surgical Mask | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-12-16 | 147 | 0 |
| K201641 | Disposable Laparoscope Trocar | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-08-06 | 51 | 0 |
| K201243 | Disposable Specimen Retrieval Bag | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-07-10 | 63 | 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