Cleared Traditional

K885347 - VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE

K885347 is an FDA 510(k) clearance for VITACOMM MODEL #140/141 ESOPHAGEAL STET..., manufactured by Vitacomm, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K885347 · Vitacomm, Inc. · Anesthesiology device
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Jan 1989
Decision
33d
Days
Class 2
Risk

K885347 is an FDA 510(k) clearance for the VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Vitacomm, Inc. (Orange, US). The FDA issued a Cleared decision on January 30, 1989 after a review of 33 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 - K885347

510(k) Number K885347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date January 30, 1989
Days to Decision 33 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 140d · This submission: 33d
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 35
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K885347.
TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
K904943 · Arzco Medical Electronics, Inc. · Apr 1991
T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
K894757 · Louisville Laboratories, Inc. · Sep 1989
YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
K893409 · Yellow Springs Instrument Co., Inc. · Jul 1989
TELEMETRIC STETHOSCOPE
K882319 · Vital Signs, Inc. · Aug 1988
SHERIDAN ELECTROSURGERY PROTECTION FILTER
K881293 · Sheridan Catheter Corp. · Jun 1988
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
K874295 · Sheridan Catheter Corp. · Nov 1987
K885347 · VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
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