Cleared Traditional

K032825 - VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR

K032825 is an FDA 510(k) clearance for VITAL VISION ARTERIAL HARDNESS AND BLOO..., manufactured by Mars Medical Products Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 457-day FDA review.

K032825 · Mars Medical Products Co., Ltd. · Cardiovascular device
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Dec 2004
Decision
457d
Days
Class 2
Risk

K032825 is an FDA 510(k) clearance for the VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Mars Medical Products Co., Ltd. (Crofton, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 457 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Mars Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K032825

510(k) Number K032825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2003
Decision Date December 10, 2004
Days to Decision 457 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
332d slower than avg
Panel avg: 125d · This submission: 457d
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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