Cleared Traditional

K812676 - AMPLITONE-3 (FDA 510(k) Clearance)

Class I Cardiovascular device.

K812676 · Progressive Technology, Inc. · Cardiovascular device
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Oct 1981
Decision
21d
Days
Class 1
Risk

K812676 is an FDA 510(k) clearance for the AMPLITONE-3. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Progressive Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 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 Progressive Technology, Inc. devices

Submission Details

510(k) Number K812676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1981
Decision Date October 13, 1981
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.

Device Classification

Product Code LDE Stethoscope, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.1875
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.