Cleared Traditional

K131000 - V-PATCH SYSTEM

K131000 is an FDA 510(k) clearance for V-PATCH SYSTEM, manufactured by Intelesens Limited. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K131000 · Intelesens Limited · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
273d
Days
Class 2
Risk

K131000 is an FDA 510(k) clearance for the V-PATCH SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Intelesens Limited (Bonita Springs, US). The FDA issued a Cleared decision on January 8, 2014 after a review of 273 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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.

FDA 510(k) Submission Details - K131000

510(k) Number K131000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2013
Decision Date January 08, 2014
Days to Decision 273 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
148d slower than avg
Panel avg: 125d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 321
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K131000.
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
K132407 · Lifewatch Technologies , Ltd. · Dec 2014
TELESENSE
K142180 · Scottcare Corporation · Dec 2014
CORCAM HEART MONITOR
K140548 · Corcam Technologia, SA · May 2014
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K124060 · Medicalgorithmics S.A. · Feb 2013
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
K121197 · Preventice, Inc. · Aug 2012
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K112921 · Medicalgorithmics S.A. · May 2012