Cleared Abbreviated

K163276 - Fully Automatic Electronic Blood Pressu...

K163276 is an FDA 510(k) clearance for Fully Automatic Electronic Blood Pressu..., manufactured by Andon Health Co, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Abbreviated 510(k) pathway after a 171-day FDA review.

K163276 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
171d
Days
Class 2
Risk

K163276 is an FDA 510(k) clearance for the Fully Automatic Electronic Blood Pressure 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 May 11, 2017 after a review of 171 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Andon Health Co, Ltd. devices

FDA 510(k) Submission Details - K163276

510(k) Number K163276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date May 11, 2017
Days to Decision 171 days
Submission Type Abbreviated
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
46d slower than avg
Panel avg: 125d · This submission: 171d
Pathway characteristics
Standards-based clearance path.

DXN Device Classification - Class 2, Special Controls

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
NCT01594307 Completed Observational Industry-sponsored

Blood Pressure Monitor Clinical Test (Cuff Range: 13.5 Cm-22cm)

85
Patients (actual)
Condition studied Blood Pressure
Eligibility All sexes · 23 Years+ · Healthy volunteers accepted
Sponsor Andon Health Co., Ltd (industry)
Started 2012-02-01 → Completed 2012-04-01
Study completed - no results published. This trial concluded in 2012 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 619
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K163276.
Fully Automatic Blood Pressure Monitor
K171282 · Andon Health Co, Ltd. · Jul 2017
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series
K163648 · Grandway Technology (Shenzhen) Limited · Jul 2017
Digital Automatic Blood Pressure Monitor MD3600
K163679 · Grandway Technology (Shenzhen) Limited · Jun 2017
HEM-9210T
K163235 · Omron Healthcare, Inc. · Apr 2017
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
K163045 · Omron Healthcare, Inc. · Feb 2017
Fully Automatic Electronic Blood Pressure Monitor
K162668 · Andon Health Co, Ltd. · Feb 2017