Cleared Special

K160014 - iHealth Track Blood Pressure Monitor

K160014 is an FDA 510(k) clearance for iHealth Track Blood Pressure Monitor, manufactured by Andon Health Co, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 29-day FDA review.

K160014 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
29d
Days
Class 2
Risk

K160014 is an FDA 510(k) clearance for the iHealth Track Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on February 2, 2016 after a review of 29 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K160014

510(k) Number K160014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2016
Decision Date February 02, 2016
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 1043
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K160014.
Oscar 2
K151520 · Suntech Medical, Inc. · Feb 2016
Arm automatic blood pressure monitor
K151258 · Shenzhen Pump Medical System Co., Ltd. · Feb 2016
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153077 · Microlife Intellectual Property GmbH · Feb 2016
Full Automatic (NIBP) Blood Pressure Monitor
K153214 · Health & Life Co., Ltd. · Jan 2016
XM-01 Electronic Automatic Blood Pressure Monitor
K150908 · Sky Innovation Technology ( Shanghai) Limited · Dec 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153450 · Microlife Intellectual Property GmbH · Dec 2015