Cleared Traditional

K063008 - HEALTH CHECK KIOSK

K063008 is the FDA 510(k) clearance for HEALTH CHECK KIOSK by Xperex Corporation. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K063008 · Xperex Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
248d
Days
Class 2
Risk

K063008 is an FDA 510(k) clearance for the HEALTH CHECK KIOSK. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Xperex Corporation (Hasbrouck Heights, US). The FDA issued a Cleared decision on June 7, 2007 after a review of 248 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 Xperex Corporation devices

Submission Details

510(k) Number K063008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date June 07, 2007
Days to Decision 248 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
123d slower than avg
Panel avg: 125d · This submission: 248d
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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