Cleared Traditional

K072008 - BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER

K072008 is an FDA 510(k) clearance for BRAEMAR ER900 WIRELESS SERIES ARRHYTHMI..., manufactured by Braemar, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K072008 · Braemar, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
72d
Days
Class 2
Risk

K072008 is an FDA 510(k) clearance for the BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Braemar, Inc. (Eagan, US). The FDA issued a Cleared decision on October 3, 2007 after a review of 72 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.

FDA 510(k) Submission Details - K072008

510(k) Number K072008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date October 03, 2007
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K072008.
MODIFICATION TO:HEALTH BUDDY APPLIANCE
K080091 · Health Hero Network, Inc. · Feb 2008
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
K073038 · Carematix, Inc. · Jan 2008
CONFIDANT 2.5
K072698 · Confidant, Inc. · Nov 2007
MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
K071564 · Philips Medical Systems · Aug 2007
RTX3370
K071953 · Rtx Healthcare A/S · Aug 2007
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
K071058 · Nihon Kohden America, Inc. · Jun 2007
K072008 · BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
Download PDF Braemar, Inc.