Cleared Traditional

K150311 - Full Automatic (NIBP)Blood Pressure Monitor

K150311 is an FDA 510(k) clearance for Full Automatic (NIBP)Blood Pressure Monitor, manufactured by Health & Life Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K150311 · Health & Life Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
190d
Days
Class 2
Risk

K150311 is an FDA 510(k) clearance for the Full Automatic (NIBP)Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Health & Life Co., Ltd. (Zhonghe District, New Taipei City, TW). The FDA issued a Cleared decision on August 18, 2015 after a review of 190 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 Health & Life Co., Ltd. devices

FDA 510(k) Submission Details - K150311

510(k) Number K150311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2015
Decision Date August 18, 2015
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K150311.
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · Andon Health Co, Ltd. · Sep 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · Andon Health Co, Ltd. · Sep 2015
Fully Automatic Electronic Blood Pressure Monitor
K151460 · Andon Health Co, Ltd. · Sep 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K141984 · Andon Health Co, Ltd. · Apr 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K143341 · Microlife Intellectual Property GmbH · Apr 2015
Full Automatic (NIBP) Blood Pressure Monitor
K142968 · Health & Life Co., Ltd. · Dec 2014