Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shanghai Carelife International Trading 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) |
|---|---|---|---|---|---|
| K221383 | MedtFine Blood Lancet | Shanghai Carelife International Trading Co. , Ltd. | 2022-09-21 | 131 | 0 |
| K131954 | MEDI PEN NEEDLE | Shanghai Carelife International Trading Co. , Ltd. | 2014-05-29 | 336 | 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