Cleared Traditional

K843071 - ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR

K843071 is the FDA 510(k) clearance for ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR by Primrose Medical, Inc.. It is a Class 2 Anesthesiology device (product code BZT) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K843071 · Primrose Medical, Inc. · Anesthesiology device
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Aug 1984
Decision
18d
Days
Class 2
Risk

K843071 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Primrose Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1984 after a review of 18 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 Primrose Medical, Inc. devices

Submission Details

510(k) Number K843071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1984
Decision Date August 24, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K843071.
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
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K823743 · Y · Jan 1983
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K812976 · Sherwood Medical Co. · Dec 1981
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862 · Mallinckrodt Critical Care · Jul 1981