Cleared Traditional

K082599 - NON-INVASIVE CONTINUOUS BLOOD PRESSURE ...

K082599 is the FDA 510(k) clearance for NON-INVASIVE CONTINUOUS BLOOD PRESSURE ... by Cnsystem Medizintechnik AG. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K082599 · Cnsystem Medizintechnik AG · Cardiovascular device
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Oct 2008
Decision
39d
Days
Class 2
Risk

K082599 is an FDA 510(k) clearance for the NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 5.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Cnsystem Medizintechnik AG (Graz, AT). The FDA issued a Cleared decision on October 17, 2008 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cnsystem Medizintechnik AG devices

Submission Details

510(k) Number K082599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date October 17, 2008
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 509
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