Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sichuan Ast Medical Equipment Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | 2024-11-22 | 73 | 0 |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2023-08-15 | 61 | 0 |
| K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2018-09-25 | 82 | 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