Cleared Traditional

STETHOSCOPE (K771504) - FDA 510(k) Clearance

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

K771504 · Swartz Medical Equipment · Cardiovascular device
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Aug 1977
Decision
21d
Days
Class 2
Risk

K771504 is an FDA 510(k) clearance for the STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Swartz Medical Equipment (Mchenry, US). The FDA issued a Cleared decision on August 26, 1977 after a review of 21 days - a notably fast clearance 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: 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 Swartz Medical Equipment devices

Submission Details

510(k) Number K771504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1977
Decision Date August 26, 1977
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
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.

Regulatory Peers - DQD Stethoscope, Electronic

All 153
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K771504.
AiSteth®
K252915 · Ai Health Highway India Pvt., Ltd. · May 2026
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eMurmur Heart AI
K252284 · Csd Labs · Dec 2025
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K251494 · Eko Health, Inc. · Aug 2025