Cardionet, Inc.: FDA clearances and approvals
Cardionet, Inc. has 7 FDA 510(k) clearances (first 2001, latest 2010), across 3 product codes in 1 review panel. Median 510(k) review time: 154 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QYX | Outpatient Cardiac Telemetry | 4 | 4 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Cardionet, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093288 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION | QYX | 2010-04-08 | 170 |
| K072558 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 | QYX | 2007-12-05 | 85 |
| K063222 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 | QYX | 2006-11-14 | 21 |
| K053263 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 | DSI | 2006-04-25 | 154 |
| K052240 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 | QYX | 2005-10-19 | 63 |
| K012241 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 | DSI | 2002-02-01 | 199 |
| K003707 | CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A | MWJ | 2001-05-16 | 166 |
Recalls
openFDA lists no recalls under a recalling firm named Cardionet, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cardionet, Inc. have?
Cardionet, Inc. has 7 FDA 510(k) clearances (first 2001, latest 2010), across 3 product codes in 1 review panel.
How long does FDA take to clear Cardionet, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cardionet, Inc.'s cleared 510(k)s is 154 days.
What devices does Cardionet, Inc. make?
Its most frequent FDA product codes are QYX (Outpatient Cardiac Telemetry, 4); DSI (Detector And Alarm, Arrhythmia, 2); MWJ (Electrocardiograph, Ambulatory (Without Analysis), 1).
Has Cardionet, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cardionet, Inc. Related entities may recall under other names.
Next steps
- See all 7 Cardionet, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QYX, Cardionet, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.