Cleared Traditional

K961060 - ARISTO ESOPHAGEAL STETHOSCOPE

K961060 is the FDA 510(k) clearance for ARISTO ESOPHAGEAL STETHOSCOPE by Aristo Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code BZT) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K961060 · Aristo Medical Products, Inc. · Anesthesiology device
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Jun 1996
Decision
93d
Days
Class 2
Risk

K961060 is an FDA 510(k) clearance for the ARISTO ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Aristo Medical Products, Inc. (Waukesha, US). The FDA issued a Cleared decision on June 19, 1996 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1920 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aristo Medical Products, Inc. devices

Submission Details

510(k) Number K961060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date June 19, 1996
Days to Decision 93 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 140d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZT Stethoscope, Esophageal, With Electrical Conductors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1920
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZT Stethoscope, Esophageal, With Electrical Conductors

All 8
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K961060.
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
K251025 · Covidien, LLC · Dec 2025
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K193027 · Deroyal Industries, Inc. · Apr 2020
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
K940169 · Deroyal Industries, Inc. · Jul 1994
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
K925789 · Deroyal Industries, Inc. · Jul 1993
TELEMETRIC STETHOSCOPE
K882319 · Vital Signs, Inc. · Aug 1988
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K823743 · Y · Jan 1983