Cleared Traditional

K152491 - MoMe Software Platform

K152491 is an FDA 510(k) clearance for MoMe Software Platform, manufactured by Infobionic, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K152491 · Infobionic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
107d
Days
Class 2
Risk

K152491 is an FDA 510(k) clearance for the MoMe Software Platform. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Infobionic, Inc. (Lowell, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 107 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 Infobionic, Inc. devices

FDA 510(k) Submission Details - K152491

510(k) Number K152491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2015
Decision Date December 17, 2015
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
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 244
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K152491.
MobileECG 2 BT
K181658 · Memtec Corporation · Mar 2019
Medicalgorithmics Unified Cardiac Rehabilitation System
K173969 · Medicalgorithmics S.A. · Jul 2018
Epicardia Anywhere
K173170 · Medicomp, Inc. · Jan 2018
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