Cleared Traditional

K973839 - DISPOSABLE ESOPHAGEAL STETHOSCOPE

K973839 is an FDA 510(k) clearance for DISPOSABLE ESOPHAGEAL STETHOSCOPE, manufactured by Catheter Research, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K973839 · Catheter Research, Inc. · Anesthesiology device
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Mar 1998
Decision
162d
Days
Class 2
Risk

K973839 is an FDA 510(k) clearance for the DISPOSABLE ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 19, 1998 after a review of 162 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K973839

510(k) Number K973839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1997
Decision Date March 19, 1998
Days to Decision 162 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
22d slower than avg
Panel avg: 140d · This submission: 162d
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 32
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K973839.
ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
K072621 · Cincinnati Sub-Zero Products, Inc. · Dec 2007
LIFESOUND ESOPHAGEAL STETHOSCOPE
K062020 · Novamed, LLC · Sep 2006
ESOPHAGEAL STETHOSCOPE
K982193 · Shore Medical, Inc. · Sep 1998
ARISTO ESOPHAGEAL STETHOSCOPE
K961060 · Aristo Medical Products, Inc. · Jun 1996
INTROSCOPE
K953793 · Polamedco, Inc. · Nov 1995
ESOPHAGEAL STETHOSCOPE
K930929 · Coast Medical Corp. · Mar 1995