Cleared Traditional

K030357 - QUANTIX/OR DEVICE

K030357 is an FDA 510(k) clearance for QUANTIX/OR DEVICE, manufactured by Cardiosonix, Ltd.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K030357 · Cardiosonix, Ltd. · Cardiovascular device
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Aug 2003
Decision
198d
Days
Class 2
Risk

K030357 is an FDA 510(k) clearance for the QUANTIX/OR 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 August 20, 2003 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiosonix, Ltd. devices

FDA 510(k) Submission Details - K030357

510(k) Number K030357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date August 20, 2003
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 79
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