Cleared Traditional

K103058 - MULTIFUNCTION KEITO

K103058 is an FDA 510(k) clearance for MULTIFUNCTION KEITO, manufactured by Aguiflai Iberica S.L.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K103058

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.

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

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