Cleared Traditional

K861023 - DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER

K861023 is an FDA 510(k) clearance for DOPPLEX, manufactured by Diagnostic Electronics Corp.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K861023 · Diagnostic Electronics Corp. · Cardiovascular device
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Nov 1986
Decision
244d
Days
Class 2
Risk

K861023 is an FDA 510(k) clearance for the DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Diagnostic Electronics Corp. (Lexington, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 244 days - an extended review 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: 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 Diagnostic Electronics Corp. devices

FDA 510(k) Submission Details - K861023

510(k) Number K861023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date November 17, 1986
Days to Decision 244 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 125d · This submission: 244d
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 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K861023.
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
K882593 · Cardio Metrics, Inc. · Aug 1988
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
K871490 · Ge Medical Systems Information Technologies · Dec 1987
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
K872068 · Advanced Technology Laboratories, Inc. · Sep 1987
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
K862720 · Sonicaid, Inc. · Nov 1986
HIGH VELOCITY CW DOPPLER SYSTEM
K862841 · Biosound, Inc. · Nov 1986
MILLAR PULSED DOPPLER VELOCIMETER
K860766 · Millar Instruments, Inc. · Jul 1986