Cleared Traditional

K945638 - TELPHONIC STETHOSCOPE

K945638 is an FDA 510(k) clearance for TELPHONIC STETHOSCOPE, manufactured by American Telecare, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K945638 · American Telecare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
182d
Days
Class 2
Risk

K945638 is an FDA 510(k) clearance for the TELPHONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by American Telecare, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 182 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 American Telecare, Inc. devices

FDA 510(k) Submission Details - K945638

510(k) Number K945638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1994
Decision Date May 17, 1995
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
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 83
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K945638.
STETHOS
K963621 · Theratechnologies, Inc. · Dec 1996
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
K961857 · Graham-Field, Inc. · Jul 1996
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
K961301 · Delphi Consulting Group · Jun 1996
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · 3M Health Care, Ltd. · Oct 1992
MASCOT STETHOSCOPE PROBE
K874726 · Imex Medical Systems, Inc. · Mar 1988
DIF-STET
K832882 · Intersect Systems, Inc. · Dec 1983