Cleared Special

K121470 - FULLY AUTOMATIC WIRELESS BLOOD PRESSURE...

K121470 is the FDA 510(k) clearance for FULLY AUTOMATIC WIRELESS BLOOD PRESSURE... by Andon Health Co, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 28-day FDA review.

K121470 · Andon Health Co, Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
28d
Days
Class 2
Risk

K121470 is an FDA 510(k) clearance for the FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR. 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 June 14, 2012 after a review of 28 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 Andon Health Co, Ltd. devices

Submission Details

510(k) Number K121470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2012
Decision Date June 14, 2012
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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

All 468
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K121470.
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