Cleared Traditional

K982193 - ESOPHAGEAL STETHOSCOPE

K982193 is an FDA 510(k) clearance for ESOPHAGEAL STETHOSCOPE, manufactured by Shore Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K982193 · Shore Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
71d
Days
Class 2
Risk

K982193 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Shore Medical, Inc. (Vista, US). The FDA issued a Cleared decision on September 1, 1998 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K982193

510(k) Number K982193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date September 01, 1998
Days to Decision 71 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
69d faster than avg
Panel avg: 140d · This submission: 71d
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 40
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K982193.
ESOPHAGEAL STETHOSCOPE
K092716 · Truer Medical, Inc. · Sep 2009
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
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K973839 · Catheter Research, Inc. · Mar 1998
ARISTO ESOPHAGEAL STETHOSCOPE
K961060 · Aristo Medical Products, Inc. · Jun 1996
INTROSCOPE
K953793 · Polamedco, Inc. · Nov 1995
K982193 · ESOPHAGEAL STETHOSCOPE
Download PDF Shore Medical, Inc.