Cleared Traditional

K953218 - AUSCULATOR GPS

K953218 is an FDA 510(k) clearance for AUSCULATOR GPS, manufactured by Lyte Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K953218 · Lyte Industries, Inc. · Cardiovascular device
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Sep 1995
Decision
70d
Days
Class 2
Risk

K953218 is an FDA 510(k) clearance for the AUSCULATOR GPS. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Lyte Industries, Inc. (Waterloo, US). The FDA issued a Cleared decision on September 18, 1995 after a review of 70 days - a notably fast clearance 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: 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 Lyte Industries, Inc. devices

FDA 510(k) Submission Details - K953218

510(k) Number K953218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date September 18, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
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 110
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K953218.
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