Cleared Traditional

K103058 - MULTIFUNCTION KEITO

K103058 is the FDA 510(k) clearance for MULTIFUNCTION KEITO by Aguiflai Iberica S.L.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K103058 · Aguiflai Iberica S.L. · Cardiovascular device
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Nov 2011
Decision
392d
Days
Class 2
Risk

K103058 is an FDA 510(k) clearance for the MULTIFUNCTION KEITO. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Aguiflai Iberica S.L. (Vilassar De Mar (Barcelona), ES). The FDA issued a Cleared decision on November 10, 2011 after a review of 392 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 Aguiflai Iberica S.L. devices

Submission Details

510(k) Number K103058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2010
Decision Date November 10, 2011
Days to Decision 392 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
267d slower than avg
Panel avg: 125d · This submission: 392d
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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