Cleared Special

K022649 - COOK-SWARTZ DOPPLER FLOW PROBE

K022649 is an FDA 510(k) clearance for COOK-SWARTZ DOPPLER FLOW PROBE, manufactured by Cook Vascular, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Special 510(k) pathway after a 28-day FDA review.

K022649 · Cook Vascular, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
28d
Days
Class 2
Risk

K022649 is an FDA 510(k) clearance for the COOK-SWARTZ DOPPLER FLOW PROBE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Cook Vascular, Inc. (Leechburg, US). The FDA issued a Cleared decision on September 6, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 - K022649

510(k) Number K022649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date September 06, 2002
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 379
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K022649 · COOK-SWARTZ DOPPLER FLOW PROBE
Download PDF FDA Summary Cook Vascular, Inc.