Cleared Special

K040229 - A&D MEDICAL LIFESOURCE DIGITAL BLOOD PR...

K040229 is the FDA 510(k) clearance for A&D MEDICAL LIFESOURCE DIGITAL BLOOD PR... by A&D Engineering, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 46-day FDA review.

K040229 · A&D Engineering, Inc. · Cardiovascular device
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Mar 2004
Decision
46d
Days
Class 2
Risk

K040229 is an FDA 510(k) clearance for the A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by A&D Engineering, Inc. (Milpitas, US). The FDA issued a Cleared decision on March 19, 2004 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all A&D Engineering, Inc. devices

Submission Details

510(k) Number K040229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date March 19, 2004
Days to Decision 46 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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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