Cleared Traditional

K860558 - ESOPHAGEAL STETHOSCOPE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K860558 · Sharn, Inc. · Anesthesiology device
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Apr 1986
Decision
46d
Days
Class 1
Risk

K860558 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE. Classified as Stethoscope, Esophageal (product code BZW), Class I - General Controls.

Submitted by Sharn, Inc. (Tampa, US). The FDA issued a Cleared decision on April 1, 1986 after a review of 46 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.

View all Sharn, Inc. devices

Submission Details

510(k) Number K860558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1986
Decision Date April 01, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 139d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.