Cleared Traditional

K250161 - Wrist Blood Pressure Monitor (AOJ-35A) (FDA 510(k) Clearance)

Also includes:
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

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

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

Submission Details

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.

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 1209
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