Cleared Traditional

K961060 - ARISTO ESOPHAGEAL STETHOSCOPE

K961060 is an FDA 510(k) clearance for ARISTO ESOPHAGEAL STETHOSCOPE, manufactured by Aristo Medical Products, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K961060

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
Combination Product No
PCCP Authorized No
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.

BZT Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K961060.
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
K111050 · Starboard Medical, LLC · Apr 2012
ESOPHAGEAL STETHOSCOPE
K982193 · Shore Medical, Inc. · Sep 1998
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K973839 · Catheter Research, Inc. · Mar 1998
INTROSCOPE
K953793 · Polamedco, Inc. · Nov 1995
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