Cleared Special

K151258 - Arm automatic blood pressure monitor

K151258 is the FDA 510(k) clearance for Arm automatic blood pressure monitor by Shenzhen Pump Medical System Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 282-day FDA review.

K151258 · Shenzhen Pump Medical System Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
282d
Days
Class 2
Risk

K151258 is an FDA 510(k) clearance for the Arm automatic blood pressure monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen Pump Medical System Co., Ltd. (Nanshan District, Shenzhen, CN). The FDA issued a Cleared decision on February 18, 2016 after a review of 282 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. 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 Shenzhen Pump Medical System Co., Ltd. devices

Submission Details

510(k) Number K151258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2015
Decision Date February 18, 2016
Days to Decision 282 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 125d · This submission: 282d
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. 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 501
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K151258.
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
K160552 · Edwards Lifesciences, LLC · Jun 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160336 · Health & Life Co., Ltd. · Mar 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160145 · Health & Life Co., Ltd. · Mar 2016
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153077 · Microlife Intellectual Property GmbH · Feb 2016
iHealth Track Blood Pressure Monitor
K160014 · Andon Health Co, Ltd. · Feb 2016
Full Automatic (NIBP) Blood Pressure Monitor
K153214 · Health & Life Co., Ltd. · Jan 2016