Cleared Traditional

K894757 - T-SCOPE

K894757 is an FDA 510(k) clearance for T-SCOPE, manufactured by Louisville Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K894757 · Louisville Laboratories, Inc. · Anesthesiology device
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Sep 1989
Decision
53d
Days
Class 2
Risk

K894757 is an FDA 510(k) clearance for the T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (Weston, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 53 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 Louisville Laboratories, Inc. devices

FDA 510(k) Submission Details - K894757

510(k) Number K894757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date September 18, 1989
Days to Decision 53 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 140d · This submission: 53d
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 17
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K894757.
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
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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
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