FDA applicant

Cardionet, Inc.

San Diego, CA7 decisions2001–20100 recalls

FDA records 7 decisions for Cardionet, Inc. (San Diego, CA) from 2001 to 2010: 7 510(k) clearances. Most are in product codes QYX (Outpatient Cardiac Telemetry) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 12 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cardionet”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardionet, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardionet, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardionet, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Cardionet, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?