Cleared Special

DOPPLER MONITOR (K110347) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K110347 · Cook Vascular, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
37d
Days
Class 2
Risk

K110347 is an FDA 510(k) clearance for the DOPPLER MONITOR. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Cook Vascular, Inc. (Vandergrift, US). The FDA issued a Cleared decision on March 16, 2011 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2100 - the FDA radiology and imaging software 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 Cook Vascular, Inc. devices

Submission Details

510(k) Number K110347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2011
Decision Date March 16, 2011
Days to Decision 37 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Radiology devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 22
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K110347.
FlowMet-R
K182494 · Laser Associated Sciences, Inc. · Feb 2019
iCertainty
K181269 · Rfpi · Dec 2018
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
K172457 · Deltex Medical Limited · Jun 2018
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · Hewlett-Packard Co. · Nov 1991
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
K902088 · Hewlett-Packard Co. · Aug 1990
EMIT TOBRAMYCIN CONTROL
K800151 · Syva Co. · Feb 1980