Cleared Traditional

K250161 - Wrist Blood Pressure Monitor (AOJ-35A)

Also marketed or referenced as:
Wrist Blood Pressure Monitor (AOJ-35B) Wrist Blood Pressure Monitor (WRS-35B) Wrist Blood Pressure Monitor (AOJ-35D) Wrist Blood Pressure Monitor (AOJ-35E) Wrist Blood Pressure Monitor (AOJ-35F) Wrist Blood Pressure Monitor (AOJ-35G) Wrist Blood Pressure Monitor (WRS-35G) Wrist Blood Pressure Monitor (WRS-35H) Wrist Blood Pressure Monitor (WRS-35K) Wrist Blood Pressure Monitor (WRS-35N) Wrist Blood Pressure Monitor (WRS-35P) Wrist Bloo

K250161 is an FDA 510(k) clearance for Wrist Blood Pressure Monitor (AOJ-35A), manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K250161 · Shenzhen AOJ Medical Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
101d
Days
Class 2
Risk

K250161 is an FDA 510(k) clearance for the Wrist Blood Pressure Monitor (AOJ-35A). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen AOJ Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 2, 2025 after a review of 101 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 Shenzhen AOJ Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K250161

510(k) Number K250161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2025
Decision Date May 02, 2025
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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 K250161.
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
K250185 · Jiangxi Aicare Medical Technology Co., Ltd. · Jul 2025
G0 Blood Pressure Monitoring System (G0)
K250415 · Aktiia SA · Jul 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
K250548 · Joytech Healthcare Co. , Ltd. · Jun 2025
Arm Blood Pressure Monitor (ARM-30A+)
K244000 · Shenzhen AOJ Medical Technology Co., Ltd. · Apr 2025
Arm Blood Pressure Monitor (ARM-30H)
K250116 · Shenzhen AOJ Medical Technology Co., Ltd. · Apr 2025
Globalcare Blood Pressure Monitor (GUS610)
K250136 · Globalcare Medical Technology Co., Ltd. · Apr 2025