Cleared Traditional

K862720 - VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES

K862720 is an FDA 510(k) clearance for VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES, manufactured by Sonicaid, Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K862720 · Sonicaid, Inc. · Cardiovascular device
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Nov 1986
Decision
123d
Days
Class 2
Risk

K862720 is an FDA 510(k) clearance for the VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sonicaid, Inc. devices

FDA 510(k) Submission Details - K862720

510(k) Number K862720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1986
Decision Date November 17, 1986
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
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 55
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K862720.
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K862841 · Biosound, Inc. · Nov 1986
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K850137 · Teca, Inc. · Aug 1985