Cleared Special

K023431 - QUANTIX/ND DEVICE

K023431 is an FDA 510(k) clearance for QUANTIX/ND 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 29-day FDA review.

K023431 · Cardiosonix, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
29d
Days
Class 2
Risk

K023431 is an FDA 510(k) clearance for the QUANTIX/ND 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 November 13, 2002 after a review of 29 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.

FDA 510(k) Submission Details - K023431

510(k) Number K023431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date November 13, 2002
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 138
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K023431.
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K010452 · Koven Technology, Inc. · Feb 2002
K023431 · QUANTIX/ND DEVICE
Download PDF FDA Summary Cardiosonix, Ltd.