Cleared Traditional

K202359 - Zio Monitor

K202359 is an FDA 510(k) clearance for Zio Monitor, 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 275-day FDA review.

K202359 · iRhythm Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
275d
Days
Class 2
Risk

K202359 is an FDA 510(k) clearance for the Zio Monitor. 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 May 21, 2021 after a review of 275 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all iRhythm Technologies, Inc. devices

FDA 510(k) Submission Details - K202359

510(k) Number K202359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2020
Decision Date May 21, 2021
Days to Decision 275 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 125d · This submission: 275d
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 78
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K202359.
QOCA Portable ECG Monitoring Device
K210179 · Quanta Computer, Inc. · Aug 2022
Strados Remote Electronic Stethoscope Platform (RESP)
K220893 · Strados Labs, Inc. · Apr 2022
LifeLens Wireless ECG Monitor
K203168 · LifeLens Technologies, Inc. · Jul 2021
QardioCore
K201644 · Qardio, Inc. · Feb 2021
Carnation Ambulatory Monitor (CAM)
K210036 · Bardy Diagnostics, Inc. · Feb 2021
M5 Recorder
K202456 · Global Instrumentation, LLC · Dec 2020