Cleared Traditional

K023338 - PORTAPRES AMBULATORY CONTINUOUS NON INV...

K023338 is the FDA 510(k) clearance for PORTAPRES AMBULATORY CONTINUOUS NON INV... by Fms, Finapres Medical Systems BV. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K023338 · Fms, Finapres Medical Systems BV · Cardiovascular device
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May 2003
Decision
214d
Days
Class 2
Risk

K023338 is an FDA 510(k) clearance for the PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Fms, Finapres Medical Systems BV (Santa Barbara, US). The FDA issued a Cleared decision on May 9, 2003 after a review of 214 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 Fms, Finapres Medical Systems BV devices

Submission Details

510(k) Number K023338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date May 09, 2003
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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

All 517
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