Cleared Traditional

K760751 - CONTINUOUS WAVE DOPPLER

K760751 is the FDA 510(k) clearance for CONTINUOUS WAVE DOPPLER by Medsonics. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K760751 · Medsonics · Cardiovascular device
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Oct 1976
Decision
12d
Days
Class 2
Risk

K760751 is an FDA 510(k) clearance for the CONTINUOUS WAVE DOPPLER. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Medsonics (Mchenry, US). The FDA issued a Cleared decision on October 13, 1976 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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.

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Submission Details

510(k) Number K760751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1976
Decision Date October 13, 1976
Days to Decision 12 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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.