Cleared Traditional

K082077 - BT3/6, BT12

K082077 is an FDA 510(k) clearance for BT3/6, manufactured by Corscience GmbH & Co. KG. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K082077 · Corscience GmbH & Co. KG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
41d
Days
Class 2
Risk

K082077 is an FDA 510(k) clearance for the BT3/6, BT12. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Corscience GmbH & Co. KG (Monroeville, US). The FDA issued a Cleared decision on September 2, 2008 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Corscience GmbH & Co. KG devices

FDA 510(k) Submission Details - K082077

510(k) Number K082077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2008
Decision Date September 02, 2008
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 175
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K082077.
ECG CHECK
K122184 · Cardiac Designs, LLC · Feb 2013
SMARTHEART
K113514 · Shl Telemedicine International , Ltd. · Feb 2012
HEALTHEPOD
K083174 · Card Guard Scientific Survival , Ltd. · Dec 2009
ECARD AND CCARD
K081471 · iRhythm Technologies, Inc. · Jun 2008
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
K060911 · Card Guard Scientific Survival , Ltd. · Aug 2006
CG-7000DX-BT ECG RECORDER/TRANSMITTER
K052556 · Card Guard Scientific Survival , Ltd. · Jan 2006