Cleared Traditional

K852228 - ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS

K852228 is an FDA 510(k) clearance for ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL ..., manufactured by Sensortek, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K852228

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.

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 29
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K852228.
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
K862672 · Inmed Corp. · Oct 1986
SHERIDAN - YSI/ECG SONATEMP (TM)
K861541 · Sheridan Catheter Corp. · Jun 1986
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
K854212 · Respiratory Support Products, Inc. · Jan 1986
SHERIDAN YSI/SONATEMP
K841098 · Sheridan Catheter Corp. · Apr 1984
CARDIO-ESOPHASCOPE
K830716 · Portex, Inc. · Aug 1983
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K823743 · Y · Jan 1983