Cleared Traditional

K121319 - ZIO PATCH

K121319 is an FDA 510(k) clearance for ZIO PATCH, manufactured by iRhythm Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K121319 · iRhythm Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
77d
Days
Class 2
Risk

K121319 is an FDA 510(k) clearance for the ZIO PATCH. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on July 18, 2012 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all iRhythm Technologies, Inc. devices

FDA 510(k) Submission Details - K121319

510(k) Number K121319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date July 18, 2012
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 112
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K121319.
Carnation Ambulatory Monitor
K143067 · Bardy Diagnostics, Inc. · Dec 2014
MYPATCH
K131190 · Dms-Service, LLC · Oct 2013
STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
K130288 · Cardiac Insight, Inc. · May 2013
ZIO PATCH
K113862 · iRhythm Technologies, Inc. · Feb 2012
MYSENSE HEART
K113176 · Cardiac Science Corporation · Dec 2011
VITALOGRAPH MODEL 7100 - VITALOJAK
K110525 · Vitalograph (Ireland) , Ltd. · Nov 2011