Cleared Traditional

STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE (K854356) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854356 · Fontaine Industries, Inc. · Cardiovascular device
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May 1986
Decision
188d
Days
Class 2
Risk

K854356 is an FDA 510(k) clearance for the STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Fontaine Industries, Inc. (Long Beach, US). The FDA issued a Cleared decision on May 5, 1986 after a review of 188 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Fontaine Industries, Inc. devices

Submission Details

510(k) Number K854356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date May 05, 1986
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 Cardiovascular devices follow this clearance model.