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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 296
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K082077.
CLUE MEDICAL AND CLUE MEDICAL BASIC
K083630 · Telovital GmbH Telemedizin · Apr 2009
HEARTRAK SMART ECAT
K083535 · Universal Medical, Inc. · Dec 2008
TEMPUSIC PATIENT MONITOR
K082718 · Remote Diagnostic Technologies , Ltd. · Oct 2008
CARDIOSEN'C
K080047 · Shl Telemedicine International , Ltd. · Jul 2008
ECARD AND CCARD
K081471 · iRhythm Technologies, Inc. · Jun 2008
HEARTRAK AF
K071130 · Universal Medical, Inc. · May 2008
K082077 · BT3/6, BT12
Download PDF FDA Summary Corscience GmbH & Co.…