Cleared Traditional

K151188 - BodyGuardian Remote Monitoring System

K151188 is an FDA 510(k) clearance for BodyGuardian Remote Monitoring System, manufactured by Preventice. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K151188 · Preventice · Cardiovascular device
Download Printable Device Report (PDF)
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Sep 2015
Decision
136d
Days
Class 2
Risk

K151188 is an FDA 510(k) clearance for the BodyGuardian Remote Monitoring System. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Preventice (Rochester, US). The FDA issued a Cleared decision on September 17, 2015 after a review of 136 days - within the typical 510(k) review window.

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.

View all Preventice devices

FDA 510(k) Submission Details - K151188

510(k) Number K151188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2015
Decision Date September 17, 2015
Days to Decision 136 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
11d slower than avg
Panel avg: 125d · This submission: 136d
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 262
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K151188.
Medicalgorithmics Unified Cardiac Rehabilitation System
K173969 · Medicalgorithmics S.A. · Jul 2018
Epicardia Anywhere
K173170 · Medicomp, Inc. · Jan 2018
Nihon Kohden Afib Detection Program QP-039P
K152305 · Nihon Kohden Corporation · Apr 2016
IntelliVue Patient Monitor
K151681 · Philips Medizin Systeme Boeblingen GmbH · Jul 2015
Medtronic Patient Asistant
K150117 · Medtronic, Inc. · May 2015
IntelliVue Patient Monitor
K150310 · Philips Medizin Systeme Boeblingen GmbH · May 2015