Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qardio, Inc. — 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) |
|---|---|---|---|---|---|
| K220106 | QardioArm 2 | Qardio, Inc. | 2022-06-15 | 154 | 0 |
| K201644 | QardioCore | Qardio, Inc. | 2021-02-28 | 256 | 0 |
| K140067 | QARDIOARM | Qardio, Inc. | 2014-06-18 | 159 | 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