Cleared Traditional

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 (K172895) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172895 · Ageless Health Industrial Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
269d
Days
Class 2
Risk

K172895 is an FDA 510(k) clearance for the AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ageless Health Industrial Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on June 18, 2018 after a review of 269 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 Ageless Health Industrial Co., Ltd. devices

Submission Details

510(k) Number K172895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2017
Decision Date June 18, 2018
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.
Cassie Lee

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 287
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K172895.
Non-invasive blood pressure measurement systems
K173024 · Joytech Healthcare Co. , Ltd. · Aug 2018
Arm Type Blood Pressure Monitor
K180155 · Avita Corporation · Aug 2018
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
K173028 · Healthstats International Pte. , Ltd. · Jun 2018
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K172880 · Microlife Intellectual Property GmbH · Apr 2018
Digital Automatic Wrist Blood Pressure Monitor MD4300
K171379 · Grandway Technology (Shenzhen) Limited · Apr 2018
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
K170605 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Mar 2018