Cleared Special

K050088 - QUANTIX/OR BLOOD FLOW MONITOR

Also marketed or referenced as:
FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER

K050088 is an FDA 510(k) clearance for QUANTIX/OR BLOOD FLOW MONITOR, manufactured by Neoprobe Corp.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Special 510(k) pathway after a 26-day FDA review.

K050088 · Neoprobe Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
26d
Days
Class 2
Risk

K050088 is an FDA 510(k) clearance for the QUANTIX/OR BLOOD FLOW MONITOR. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Neoprobe Corp. (Dublin, US). The FDA issued a Cleared decision on February 8, 2005 after a review of 26 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. 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.

View all Neoprobe Corp. devices

FDA 510(k) Submission Details - K050088

510(k) Number K050088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2005
Decision Date February 08, 2005
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 70
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K050088.
SENSILASE PAD-IQ
K110438 · Vasamed, Inc. · May 2011
DOPPLER MONITOR
K110347 · Cook Vascular, Inc. · Mar 2011
SMARTDOP 45 VASCULAR DOPPLER
K050601 · Koven Technology, Inc. · Apr 2005
ECHO SOUNDER EX-101EX 8 MHZ
K031931 · Koven Technology, Inc. · Feb 2004
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
K033424 · Transonic Systems, Inc. · Dec 2003
MONITOR, MODEL HSM-00200
K031153 · Arrow Intl., Inc. · Nov 2003