510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121319Substantially Equivalent

Zio Patch

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

K121319 is the FDA 510(k) clearance record for ZIO PATCH, a class II device, cleared for iRhythm Technologies, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 18 510(k) clearances for iRhythm Technologies, Inc., from to . As of , FDA records show no recalls naming K121319.

Clearance record

Decision date
Received
(77 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
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
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260