Cleared Traditional

K823743 - MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO

K823743 is an FDA 510(k) clearance for MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO, manufactured by Y. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K823743 · Y · Anesthesiology device
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Jan 1983
Decision
36d
Days
Class 2
Risk

K823743 is an FDA 510(k) clearance for the MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Y (Mchenry, US). The FDA issued a Cleared decision on January 18, 1983 after a review of 36 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 Y devices

FDA 510(k) Submission Details - K823743

510(k) Number K823743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1982
Decision Date January 18, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
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 21
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K823743.
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
K854212 · Respiratory Support Products, Inc. · Jan 1986
SHERIDAN YSI/SONATEMP
K841098 · Sheridan Catheter Corp. · Apr 1984
CARDIO-ESOPHASCOPE
K830716 · Portex, Inc. · Aug 1983
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
K821890 · Critikon Company, LLC · Aug 1982
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K812976 · Sherwood Medical Co. · Dec 1981
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862 · Mallinckrodt Critical Care · Jul 1981