Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cardionet, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
199 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093288 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION | Cardionet, Inc. | 2010-04-08 | 170 | 0 |
| K072558 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2007-12-05 | 85 | 0 |
| K063222 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2006-11-14 | 21 | 0 |
| K053263 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2006-04-25 | 154 | 0 |
| K052240 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2005-10-19 | 63 | 0 |
| K012241 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, | Cardionet, Inc. | 2002-02-01 | 199 | 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