Cleared Special

K102356 - FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534

K102356 is an FDA 510(k) clearance for FULLY AUTOMATIC ELECTRONIC BLOOD PRESSU..., manufactured by Andon Health Co, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 32-day FDA review.

K102356 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
32d
Days
Class 2
Risk

K102356 is an FDA 510(k) clearance for the FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on September 20, 2010 after a review of 32 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.

FDA 510(k) Submission Details - K102356

510(k) Number K102356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2010
Decision Date September 20, 2010
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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

All 1149
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K102356.
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K102356 · FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
Download PDF FDA Summary Andon Health Co, Ltd.