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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 1143
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K042109.
MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR
K050039 · Mars Medical Products · Mar 2005
MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
K050697 · Nihon Seimitsu Sokki Co., Ltd. · Mar 2005
KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K042418 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Mar 2005
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
K050413 · Amplife Corporation · Mar 2005
A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
K043217 · A&D Engineering, Inc. · Mar 2005
MEDICOMPASS CONNECT
K042768 · Imetrikus, Inc. · Feb 2005
K042109 · DIASYS INTEGRA II
Download PDF FDA Summary Novacor France