Cleared Traditional

K842865 - ESOPHAGEAL STETHOSCOPE

K842865 is an FDA 510(k) clearance for ESOPHAGEAL STETHOSCOPE, manufactured by Inmed Corp.. The device is a Class 1 Anesthesiology device with product code BZW cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K842865 · Inmed Corp. · Anesthesiology device
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Aug 1984
Decision
23d
Days
Class 1
Risk

K842865 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal (product code BZW), Class I - General Controls.

Submitted by Inmed Corp. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1910 - 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 - K842865

510(k) Number K842865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date August 15, 1984
Days to Decision 23 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
117d faster than avg
Panel avg: 140d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

BZW Device Classification - Class 1, General Controls

Product Code BZW Stethoscope, Esophageal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZW Stethoscope, Esophageal

All 12
Devices cleared under the same product code (BZW) and FDA review panel - the closest regulatory comparables to K842865.
ESOPHAGEAL STETHOSCOPE
K844444 · Medical Parameters, Inc. · Jan 1985
ESOPHAGEAL STETHOSCOPES
K843070 · Primrose Medical, Inc. · Aug 1984
QUAZAR ESOPHAGEAL STETHOSCOPE
K841574 · Axiom Medical, Inc. · Aug 1984
ESOPHAGEAL STETHOSCOPE
K830329 · Science Development Corp. · Mar 1983
SHERIDAN/ESOPHAGEAL STETHOSCOPE
K830218 · Sheridan Catheter Corp. · Mar 1983
ESOPHAGEAL STETHOSCOPE
K823703 · Rsp, Inc. · Jan 1983
K842865 · ESOPHAGEAL STETHOSCOPE
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