Cleared Traditional

K151281 - AGE Automatic Wrist Blood Pressure Monitor

K151281 is an FDA 510(k) clearance for AGE Automatic Wrist Blood Pressure Monitor, manufactured by Dongguan Ageless Health Industrial Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K151281 · Dongguan Ageless Health Industrial Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
47d
Days
Class 2
Risk

K151281 is an FDA 510(k) clearance for the AGE Automatic Wrist Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Dongguan Ageless Health Industrial Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on June 30, 2015 after a review of 47 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 Dongguan Ageless Health Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K151281

510(k) Number K151281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2015
Decision Date June 30, 2015
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 Consultant

Guangzhou GLOMED Biological Technology Co., Ltd.
CECILIA CENG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K151281.
Digital Automatic Blood Pressure Monitor MD2300
K143735 · Grandway Technology (Shenzhen) Limited · Jul 2015
Microlife Wrist Watch Blood Pressure Monitor
K151330 · Microlife Intellectual Property GmbH, Switzerland · Jul 2015
AUTOMATIC BLOOD PRESSURE MONITOR
K140762 · Jawon Medical Co., Ltd. · Jul 2015
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
K150373 · Grandway Technology (Shenzhen) Limited · Jun 2015
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810
K143734 · Grandway Technology (Shenzhen) Limited · May 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K141984 · Andon Health Co, Ltd. · Apr 2015