Cleared Traditional

K142468 - Stealth Monitor

K142468 is an FDA 510(k) clearance for Stealth Monitor, manufactured by Cardiac Insight, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K142468 · Cardiac Insight, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
311d
Days
Class 2
Risk

K142468 is an FDA 510(k) clearance for the Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Dis.... Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardiac Insight, Inc. (Seattle, US). The FDA issued a Cleared decision on July 11, 2015 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cardiac Insight, Inc. devices

FDA 510(k) Submission Details - K142468

510(k) Number K142468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2014
Decision Date July 11, 2015
Days to Decision 311 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 125d · This submission: 311d
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 86
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K142468.
ECG recorder and Arrhythmia Detector
K173461 · Smart Solutions Technologies SL · Aug 2018
Portable ECG Monitor (ECG3)
K172862 · Andon Health Co, Ltd. · Jul 2018
ePatch
K171410 · Braemar Manufacturing, LLC · Jan 2018
ZIO SR ECG Monitoring Service
K143513 · iRhythm Technologies, Inc. · Jun 2015
ZIO PATCH
K121319 · iRhythm Technologies, Inc. · Jul 2012
ZIO PATCH
K113862 · iRhythm Technologies, Inc. · Feb 2012