Cleared Traditional

E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 (K961301) - FDA 510(k) Clearance

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

K961301 · Delphi Consulting Group · Cardiovascular device
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Jun 1996
Decision
68d
Days
Class 2
Risk

K961301 is an FDA 510(k) clearance for the E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Delphi Consulting Group (Houston, US). The FDA issued a Cleared decision on June 11, 1996 after a review of 68 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 Delphi Consulting Group devices

Submission Details

510(k) Number K961301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date June 11, 1996
Days to Decision 68 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 125d · This submission: 68d
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.