Cleared Special

K102939 - FULLY AUTOMATIC ELECTRONIC BLOOD PRESSU...

K102939 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 142-day FDA review.

K102939 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
142d
Days
Class 2
Risk

K102939 is an FDA 510(k) clearance for the FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931. 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 February 23, 2011 after a review of 142 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K102939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date February 23, 2011
Days to Decision 142 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
17d slower than avg
Panel avg: 125d · This submission: 142d
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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01206959 Completed Observational Industry-sponsored

Clinical Test for Armed-used Blood Pressure Monitor With Preformed Cuff(Monitor When Being Inflated)

88
Patients (actual)
Condition studied Blood Pressure
Eligibility All sexes · 40 Years+ · Healthy volunteers accepted
Sponsor Andon Health Co., Ltd (industry)
Study completed - no results published. This trial concluded in but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 491
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K102939.
SURESIGNS VS2 VITAL SIGNS MONITOR
K111114 · Philips Medical Systems · May 2011
HEM-4030
K110501 · Omron Healthcare, Inc. · Mar 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110018 · Andon Health Co, Ltd. · Mar 2011
INFINITY CNAP SMARTPOD
K102968 · Draeger Medical Systems, Inc. · Feb 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110330 · Andon Health Co, Ltd. · Feb 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102690 · Andon Health Co, Ltd. · Nov 2010