Cleared Special

K113862 - ZIO PATCH

K113862 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 Special 510(k) pathway after a 38-day FDA review.

K113862 · iRhythm Technologies, Inc. · Cardiovascular device
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Feb 2012
Decision
38d
Days
Class 2
Risk

K113862 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 February 6, 2012 after a review of 38 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K113862

510(k) Number K113862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2011
Decision Date February 06, 2012
Days to Decision 38 days
Submission Type Special
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
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

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 192
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K113862.
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K113176 · Cardiac Science Corporation · Dec 2011
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K110525 · Vitalograph (Ireland) , Ltd. · Nov 2011
GLOBALCARDIO
K111320 · Cardiocomm Solutions, Inc. · Oct 2011
K113862 · ZIO PATCH
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