Cleared Abbreviated

K222869 - Arm Blood Pressure Monitor

K222869 is the FDA 510(k) clearance for Arm Blood Pressure Monitor by Andon Health Co, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Abbreviated 510(k) pathway after a 146-day FDA review.

K222869 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
146d
Days
Class 2
Risk

K222869 is an FDA 510(k) clearance for the Arm 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 15, 2023 after a review of 146 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K222869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2022
Decision Date February 15, 2023
Days to Decision 146 days
Submission Type Abbreviated
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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Standards-based clearance path.

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

All 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K222869.
Task Force CORE
K223332 · Cnsystems Medizintechnik GmbH · Apr 2023
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
K222887 · Famidoc Technology Company Limited · Apr 2023
Electronic Sphygmomanometers
K222394 · Qingdao Yasee Medical Device Co., Ltd. · Mar 2023
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
K222153 · Microlife Intellectual Property GmbH · Feb 2023
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
K222125 · Shenzhen AOJ Medical Technology Co., Ltd. · Dec 2022
GUS610 Blood pressure monitor
K222160 · Globalcare Medical Technology Co., Ltd. · Nov 2022