Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Choice Smart Health Care 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) |
|---|---|---|---|---|---|
| K062952 | C300 SERIES AIR NEBULIZER COMPRESSOR | Choice Smart Health Care Co. , Ltd. | 2007-02-21 | 145 | 0 |
| K063291 | INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 | Choice Smart Health Care Co. , Ltd. | 2006-11-21 | 20 | 0 |
| K062016 | RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES | Choice Smart Health Care Co. , Ltd. | 2006-10-27 | 102 | 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