Cleared Traditional

K244000 - Arm Blood Pressure Monitor (ARM-30A+)

Also marketed or referenced as:
Arm Blood Pressure Monitor (ARM-30G2) Arm Blood Pressure Monitor (ARM-30Q) Arm Blood Pressure Monitor (ARM-30E+)

K244000 is an FDA 510(k) clearance for Arm Blood Pressure Monitor (ARM-30A+), 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 125-day FDA review.

K244000 · Shenzhen AOJ Medical Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
125d
Days
Class 2
Risk

K244000 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor (ARM-30A+). 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 April 30, 2025 after a review of 125 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 - K244000

510(k) Number K244000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2024
Decision Date April 30, 2025
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
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 K244000.
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
Wrist Blood Pressure Monitor (AOJ-35A)
K250161 · Shenzhen AOJ Medical Technology Co., Ltd. · May 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
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
K250091 · Korot Co., Ltd. · Mar 2025