Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guangzhou Zhengkang Medical Equipment Co.,Ltd · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222204 | Medical Surgical Mask | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 2022-09-23 | 60 | 0 |
| K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17 | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 2021-11-05 | 92 | 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