Cleared Traditional

K080326 - KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K080326 is an FDA 510(k) clearance for KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD ..., manufactured by Andon Health Co, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K080326 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
176d
Days
Class 2
Risk

K080326 is an FDA 510(k) clearance for the KD-391 SEMI 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. (Tiajin, CN). The FDA issued a Cleared decision on July 31, 2008 after a review of 176 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080326

510(k) Number K080326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2008
Decision Date July 31, 2008
Days to Decision 176 days
Submission Type Traditional
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
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 1207
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K080326.
HEM-9000AI
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K072109 · Ramsey Medical, Inc. · Jul 2008
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K080319 · Andon Health Co, Ltd. · Jul 2008
YA HORNG ARM TYPE DIGITAL BLOOD PRESSURE MONITOR, MODELS BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J
K081590 · Ya Horng Electronic Co., Ltd. · Jun 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
K080337 · Microlife Corp. · May 2008
K080326 · KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Download PDF FDA Summary Andon Health Co, Ltd.