Cleared Traditional

K053378 - LOOP RECORDER VITAPHONE, 3100 SERIES

K053378 is an FDA 510(k) clearance for LOOP RECORDER VITAPHONE, manufactured by Tms Telemedizinische Systeme GmbH. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K053378 · Tms Telemedizinische Systeme GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
80d
Days
Class 2
Risk

K053378 is an FDA 510(k) clearance for the LOOP RECORDER VITAPHONE, 3100 SERIES. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Tms Telemedizinische Systeme GmbH (Chemnitz, DE). The FDA issued a Cleared decision on February 23, 2006 after a review of 80 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 Tms Telemedizinische Systeme GmbH devices

FDA 510(k) Submission Details - K053378

510(k) Number K053378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date February 23, 2006
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 157
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