Cleared Traditional

K160557 - Full Automatic (NIBP) Blood Pressure Mo...

K160557 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 128-day FDA review.

K160557 · Health & Life Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
128d
Days
Class 2
Risk

K160557 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 July 6, 2016 after a review of 128 days - within the typical 510(k) review window.

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 - K160557

510(k) Number K160557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date July 06, 2016
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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 K160557.
Full Automatic (NIBP) Blood Pressure Monitor
K162338 · Health & Life Co., Ltd. · Sep 2016
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
K161156 · Health & Life Co., Ltd. · Jun 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