Cleared Traditional

K161156 - Full Automatic (NIBP) Blood Pressure Mo...

K161156 is an FDA 510(k) clearance for Full Automatic (NIBP) Blood Pressure Mo..., 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 50-day FDA review.

K161156 · Health & Life Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
50d
Days
Class 2
Risk

K161156 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, CN). The FDA issued a Cleared decision on June 14, 2016 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health & Life Co., Ltd. devices

FDA 510(k) Submission Details - K161156

510(k) Number K161156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2016
Decision Date June 14, 2016
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
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 K161156.
Fully Automatic Electronic Blood Pressure Monitor
K160565 · Andon Health Co, Ltd. · Aug 2016
Fully Automatic Electronic Blood Pressure Monitor
K160563 · Andon Health Co, Ltd. · Aug 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160557 · Health & Life Co., Ltd. · Jul 2016
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