510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081471Substantially Equivalent

Ecard and Ccard

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

K081471 is the FDA 510(k) clearance record for ECARD AND CCARD, a class II device, cleared for iRhythm Technologies, Inc. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list 18 510(k) clearances for iRhythm Technologies, Inc., from to . As of , FDA records show no recalls naming K081471.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
iRhythm Technologies, Inc. 650 Townsend St., Suite 380, San Francisco CA
510(k) summary
Statement
Third party review
Yes

Clearances, product code DXH

Trailing 12 months
4 clearances under product code DXH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DXH, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260