Cleared Traditional

K160967 - Finapres Nova Noninvasive Hemodynamic M...

K160967 is the FDA 510(k) clearance for Finapres Nova Noninvasive Hemodynamic M... by Finapres Medical Systems B.V.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K160967 · Finapres Medical Systems B.V. · Cardiovascular device
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Apr 2017
Decision
377d
Days
Class 2
Risk

K160967 is an FDA 510(k) clearance for the Finapres Nova Noninvasive Hemodynamic Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Finapres Medical Systems B.V. (Amsterdam, NL). The FDA issued a Cleared decision on April 18, 2017 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Finapres Medical Systems B.V. devices

Submission Details

510(k) Number K160967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2016
Decision Date April 18, 2017
Days to Decision 377 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
252d slower than avg
Panel avg: 125d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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