Cleared Traditional

MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 (K071564) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071564 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
85d
Days
Class 2
Risk

K071564 is an FDA 510(k) clearance for the MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems devices

Submission Details

510(k) Number K071564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2007
Decision Date August 31, 2007
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 190
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K071564.
Perin Health System (PHD80060-2)
K252984 · Perin Health Devices, LLC · Jan 2026
EasyTeleMed (2.0.2)
K252440 · Ingeniars S.R.L. · Oct 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
K250259 · The ScottCare Corporation · Jun 2025
iBSM
K243837 · Iorbit Digital Technologies Private Limited · May 2025
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018 · Lifesignals, Inc. · Nov 2024
BioButton System
K241101 · Biointellisense, Inc. · Sep 2024