Cleared Special

K091739 - SEMI AUTOMATIC ELECTRONIC BLOOD PRESSUR...

K091739 is the FDA 510(k) clearance for SEMI AUTOMATIC ELECTRONIC BLOOD PRESSUR... by Andon Health Co, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 68-day FDA review.

K091739 · Andon Health Co, Ltd. · Cardiovascular device
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Aug 2009
Decision
68d
Days
Class 2
Risk

K091739 is an FDA 510(k) clearance for the SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909. 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 August 18, 2009 after a review of 68 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 K091739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date August 18, 2009
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
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 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K091739.
BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
K091897 · Taidoc Technology Corporation · Aug 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031
K091737 · Andon Health Co, Ltd. · Aug 2009
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD
K091738 · Andon Health Co, Ltd. · Aug 2009
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K091500 · Andon Health Co, Ltd. · Jul 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962
K091997 · Andon Health Co, Ltd. · Jul 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
K092045 · Andon Health Co, Ltd. · Jul 2009