Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhongshan A&J Medical Equipment 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) |
|---|---|---|---|---|---|
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | 2026-04-03 | 185 | 0 |
| K121531 | A&J 5L POCA SERIES OXYGEN CONCENTRATOR | Zhongshan A&J Medical Equipment Co., Ltd. | 2012-07-17 | 54 | 0 |
| K071608 | A&J POCA01 OXYGEN CONCENTRATOR | Zhongshan A&J Medical Equipment Co., Ltd. | 2008-01-11 | 213 | 0 |
| K071607 | ASA01 HEAVY DUTY SUCTION PUMP | Zhongshan A&J Medical Equipment Co., Ltd. | 2007-06-26 | 14 | 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