510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163512Substantially Equivalent

Zio AT ECG Monitoring System

iRhythm Technologies, Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163512 is the FDA 510(k) clearance record for Zio AT ECG Monitoring System, a class II device, cleared for iRhythm Technologies, Inc. on under FDA product code QYX (Outpatient Cardiac Telemetry). FDA's definition for product code QYX reads: "Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing...". FDA records list 18 510(k) clearances for iRhythm Technologies, Inc., from to . As of , FDA records show one recall naming K163512.

Clearance record

Decision date
Received
(169 days to decision)
Product code
QYX Outpatient Cardiac Telemetry
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
iRhythm Technologies, Inc. 650 Townsend St., Suite 380, San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYX

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