510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053263Substantially Equivalent

Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model Cn1003

Cardionet, LLC, San Diego CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053263 is the FDA 510(k) clearance record for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003, a class II device, cleared for Cardionet, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 7 510(k) clearances for Cardionet, Inc., from to . As of , FDA records show no recalls naming K053263.

Clearance record

Decision date
Received
(154 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardionet, Inc. 1010 2nd Ave., Suite 700, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260