Cleared Traditional

K963418 - TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE

K963418 is an FDA 510(k) clearance for TRANSMEDICA MODEL 100 DIGITAL ELECTRONI..., manufactured by Transmedica, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K963418 · Transmedica, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
245d
Days
Class 2
Risk

K963418 is an FDA 510(k) clearance for the TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Transmedica, Inc. (Vienna, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Transmedica, Inc. devices

FDA 510(k) Submission Details - K963418

510(k) Number K963418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date May 02, 1997
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 - DQD Stethoscope, Electronic

All 82
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K963418.
MEDITRON STETHOSCOPE SYSTEM
K991367 · Meditron AS · Jul 1999
CADISCOPE ELECTRONIC STETHOSCOPE
K990809 · Caditec AG · Jun 1999
3M LITTMANN ELECTRONIC STETHOSCOPE
K961848 · Minnesota Mining and Mfg. Co. · Sep 1997
CARETONE II
K963678 · American Telecare, Inc. · Feb 1997
SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
K961937 · Delphi Consulting Group · Dec 1996
STETHOS
K963621 · Theratechnologies, Inc. · Dec 1996