Cleared Special

K010482 - ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM

Also marketed or referenced as:
MODEL PEF-1

K010482 is an FDA 510(k) clearance for ECHOFLOW PORTABLE DOPPLER BLOOD FLOW ME..., manufactured by Echocath, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Special 510(k) pathway after a 28-day FDA review.

K010482 · Echocath, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
28d
Days
Class 2
Risk

K010482 is an FDA 510(k) clearance for the ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM. 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 March 20, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010482

510(k) Number K010482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date March 20, 2001
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K010482.
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
K131860 · Us Vascular, LLC · Sep 2013
FALCON
K111416 · Viasonix , Ltd. · Jul 2011
STUDIODOP VICORDER
K071730 · Skidmore Medical, Limited · Dec 2007
NICOLET VASOGUARD
K002766 · Nicolet Biomedical · Nov 2000
ECHOFLOW DOPPLER BLOOD VELOCITY METER
K990642 · Echocath, Inc. · Sep 1999
SPECTRADOP
K925078 · Bennett and Assoc., Inc. · Jul 1995
K010482 · ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM
Download PDF FDA Summary Echocath, Inc.