Cleared Special

K093387 - FULLY AUTOMATIC ELECTRONIC BLOOD PRESSU...

K093387 is the FDA 510(k) clearance for FULLY AUTOMATIC ELECTRONIC BLOOD PRESSU... 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.

K093387 · Andon Health Co, Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 2009
Decision
28d
Days
Class 2
Risk

K093387 is an FDA 510(k) clearance for the FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-.... 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 November 27, 2009 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 K093387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2009
Decision Date November 27, 2009
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 492
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K093387.
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911
K092510 · Andon Health Co, Ltd. · Dec 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
K093452 · Andon Health Co, Ltd. · Dec 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
K093528 · Andon Health Co, Ltd. · Dec 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
K092163 · Health & Life Co., Ltd. · Nov 2009
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
K092456 · Microlife Intellectual Property GmbH · Oct 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
K092161 · Health & Life Co., Ltd. · Sep 2009