Cleared Traditional

K943495 - DISPOSABLE ESOPHAGEAL STETHOSCOPE

K943495 is an FDA 510(k) clearance for DISPOSABLE ESOPHAGEAL STETHOSCOPE, manufactured by Coast Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K943495 · Coast Medical, Inc. · Anesthesiology device
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Sep 1994
Decision
51d
Days
Class 2
Risk

K943495 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 Coast Medical, Inc. (Orange, US). The FDA issued a Cleared decision on September 8, 1994 after a review of 51 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.

View all Coast Medical, Inc. devices

FDA 510(k) Submission Details - K943495

510(k) Number K943495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date September 08, 1994
Days to Decision 51 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 140d · This submission: 51d
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 30
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K943495.
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
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
YSI MODEL 441A AIRWAY TEMPERATURE PROBE
K922007 · Yellow Springs Instrument Co., Inc. · Nov 1992