Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Xiamen Probtain Medical Techology Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-03-07 | 118 | 0 |
| K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-01-04 | 56 | 0 |
| K202954 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | 2021-07-02 | 275 | 0 |
| K201893 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | 2020-12-09 | 154 | 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