Cleared Special

K101010 - FULLY AUTOMATIC ELECTRONIC BLOOD PRESSU...

K101010 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 109-day FDA review.

K101010 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
109d
Days
Class 2
Risk

K101010 is an FDA 510(k) clearance for the FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008. 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 July 30, 2010 after a review of 109 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 K101010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2010
Decision Date July 30, 2010
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
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
NCT00723814 Completed Observational Industry-sponsored

Blood Pressure Monitor Clinical Test

Condition studied Blood Pressure
Sponsor Andon Health Co., Ltd (industry)
Primary outcome
monitor the diastolic and systolic
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 492
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K101010.
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
K102353 · Andon Health Co, Ltd. · Sep 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
K101950 · Andon Health Co, Ltd. · Aug 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4
K100763 · Microlife Intellectual Property GmbH · Aug 2010
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
K100658 · Taidoc Technology Corporation · Jul 2010
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
K101680 · Welch Allyn, Inc. · Jul 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4).
K101512 · Microlife Intellectual Property GmbH · Jul 2010