Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microlife Corporation · 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) |
|---|---|---|---|---|---|
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | 2026-07-23 | 113 | 0 |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | 2026-06-23 | 270 | 0 |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Corporation | 2025-08-06 | 117 | 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