Cleared Traditional

K852228 - ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL ...

K852228 is the FDA 510(k) clearance for ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL ... by Sensortek, Inc.. It is a Class 2 Anesthesiology device (product code BZT) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K852228 · Sensortek, Inc. · Anesthesiology device
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Sep 1985
Decision
104d
Days
Class 2
Risk

K852228 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Sensortek, Inc. (Clifton, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 104 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 Sensortek, Inc. devices

Submission Details

510(k) Number K852228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1985
Decision Date September 03, 1985
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
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 K852228.
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
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K812976 · Sherwood Medical Co. · Dec 1981
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862 · Mallinckrodt Critical Care · Jul 1981