Cleared Traditional

K130925 - AUTOMATIC BLOOD PRESSURE MONITOR

K130925 is an FDA 510(k) clearance for AUTOMATIC BLOOD PRESSURE MONITOR, manufactured by Honsun (Nantong) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K130925 · Honsun (Nantong) Co., Ltd. · Cardiovascular device
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Sep 2013
Decision
162d
Days
Class 2
Risk

K130925 is an FDA 510(k) clearance for the AUTOMATIC BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Honsun (Nantong) Co., Ltd. (Nantong, Jiangsu, CN). The FDA issued a Cleared decision on September 12, 2013 after a review of 162 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.

View all Honsun (Nantong) Co., Ltd. devices

FDA 510(k) Submission Details - K130925

510(k) Number K130925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2013
Decision Date September 12, 2013
Days to Decision 162 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 125d · This submission: 162d
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 566
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K130925.
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IHEALTH CLOUD
K131203 · Andon Health Co, Ltd. · Jul 2013
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