Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dailycare Biomedical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
294 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172778 | CheckMyHeart Plus | Dailycare Biomedical, Inc. | 2018-07-05 | 294 | 0 |
| K062894 | INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 | Dailycare Biomedical, Inc. | 2007-02-08 | 134 | 0 |
| K052303 | READMYHEART, MODEL RMH2.0 | Dailycare Biomedical, Inc. | 2005-12-16 | 114 | 0 |
| K050620 | READMYHEART, MODEL RMH3.0 | Dailycare Biomedical, Inc. | 2005-07-14 | 126 | 0 |
| K042814 | READMYHEART | Dailycare Biomedical, Inc. | 2005-01-06 | 86 | 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