Cleared Special

K110347 - DOPPLER MONITOR

K110347 is an FDA 510(k) clearance for DOPPLER MONITOR, manufactured by Cook Vascular, Inc.. The device is a Class 2 Radiology device with product code DPW cleared through the Special 510(k) pathway after a 37-day FDA review.

K110347 · Cook Vascular, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K110347

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
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 Radiology devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 97
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K110347.
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VTI INTRAOPERATIVE DOPPLER SYSTEMS
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K110347 · DOPPLER MONITOR
Download PDF FDA Summary Cook Vascular, Inc.