Cleared Special

K041180 - QUANTIX OR VESSEL STABILIZER DEVICE

K041180 is an FDA 510(k) clearance for QUANTIX OR VESSEL STABILIZER DEVICE, manufactured by Cardiosonix, Ltd.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Special 510(k) pathway after a 32-day FDA review.

K041180 · Cardiosonix, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2004
Decision
32d
Days
Class 2
Risk

K041180 is an FDA 510(k) clearance for the QUANTIX OR VESSEL STABILIZER DEVICE. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Cardiosonix, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on June 7, 2004 after a review of 32 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 Cardiosonix, Ltd. devices

FDA 510(k) Submission Details - K041180

510(k) Number K041180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2004
Decision Date June 07, 2004
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
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 78
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