Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Foshan Care Medical Technology 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) |
|---|---|---|---|---|---|
| K240840 | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | 2024-12-06 | 254 | 0 |
| K130001 | CARE SU01A SUCTION ASPIRATOR | Foshan Care Medical Technology Co., Ltd. | 2013-07-25 | 204 | 0 |
| K101552 | FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 | Foshan Care Medical Technology Co., Ltd. | 2011-03-14 | 283 | 0 |
| K102245 | CARE ZY5BA OXYGEN CONCENTRATOR | Foshan Care Medical Technology Co., Ltd. | 2010-11-09 | 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