Cleared Traditional

K780302 - BLOOD FLOWMETER SYSTEM

K780302 is an FDA 510(k) clearance for BLOOD FLOWMETER SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K780302 · Medtronic Vascular · Cardiovascular device
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Apr 1978
Decision
58d
Days
Class 2
Risk

K780302 is an FDA 510(k) clearance for the BLOOD FLOWMETER SYSTEM. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on April 21, 1978 after a review of 58 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.

FDA 510(k) Submission Details - K780302

510(k) Number K780302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1978
Decision Date April 21, 1978
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 138
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K780302.
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE
K801802 · Medical Testing System, Inc. · Jan 1981
EMIT TOBRAMYCIN CONTROL
K800151 · Syva Co. · Feb 1980
VASCULIZER
K791418 · Diagnostics Intl. · Oct 1979
ARTERIAL DIAGNOSTIC UNIT (ADU)
K770115 · Medical Electronic Devices, Inc. · Feb 1977
P-1 ULTRASONIC ARTERIOGRAPH
K761288 · D. Eugene Hokanson · Dec 1976
CONTINUOUS WAVE DOPPLER
K760751 · Medsonics · Oct 1976
K780302 · BLOOD FLOWMETER SYSTEM
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