Cleared Traditional

K042109 - DIASYS INTEGRA II

K042109 is an FDA 510(k) clearance for DIASYS INTEGRA II, manufactured by Novacor France. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K042109 · Novacor France · Cardiovascular device
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Mar 2005
Decision
216d
Days
Class 2
Risk

K042109 is an FDA 510(k) clearance for the DIASYS INTEGRA II. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Novacor France (Rueil Malmaison Cedex, FR). The FDA issued a Cleared decision on March 9, 2005 after a review of 216 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Novacor France devices

FDA 510(k) Submission Details - K042109

510(k) Number K042109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2004
Decision Date March 09, 2005
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 732
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