Cleared Traditional

K990642 - ECHOFLOW DOPPLER BLOOD VELOCITY METER

K990642 is an FDA 510(k) clearance for ECHOFLOW DOPPLER BLOOD VELOCITY METER, manufactured by Echocath, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K990642 · Echocath, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
202d
Days
Class 2
Risk

K990642 is an FDA 510(k) clearance for the ECHOFLOW DOPPLER BLOOD VELOCITY METER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Echocath, Inc. (Monmouth Junction, US). The FDA issued a Cleared decision on September 16, 1999 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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.

FDA 510(k) Submission Details - K990642

510(k) Number K990642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1999
Decision Date September 16, 1999
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 65
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K990642.
STUDIODOP VICORDER
K071730 · Skidmore Medical, Limited · Dec 2007
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM
K010482 · Echocath, Inc. · Mar 2001
NICOLET VASOGUARD
K002766 · Nicolet Biomedical · Nov 2000
SPECTRADOP
K925078 · Bennett and Assoc., Inc. · Jul 1995
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
K934638 · Koven Technology, Inc. · May 1994
MODEL HD-207 BIDIRECTIONAL VELOCITY METER
K912409 · Koven and Assoc., Inc. · Dec 1991
K990642 · ECHOFLOW DOPPLER BLOOD VELOCITY METER
Download PDF FDA Summary Echocath, Inc.