Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Digio2 International 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) |
|---|---|---|---|---|---|
| K133105 | BREEZE NEBULIZER (NBR-10X) | Digio2 International Co., Ltd. | 2014-06-24 | 267 | 0 |
| K112189 | THERMO PAL INFRARED EAR THERMOMETER | Digio2 International Co., Ltd. | 2012-01-13 | 168 | 0 |
| K091430 | CARE PAL, MODEL CPW-10X | Digio2 International Co., Ltd. | 2009-08-21 | 99 | 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