Cleared Special

K260276 - Arm Blood Pressure Monitor Models: ARM-30C+ (FDA 510(k) Clearance)

Also includes:
ARM-30M+ ARM-HA101+ ARM-3060 XS Pro ARM-30G1 ARM-30H Visomat double comfort Visomat comfort 20/40 BT ARM-3080 ARM-3081 ARM-3082 ARM-3103 ARM-3200 ARM-115 ARM-111 ARM-3102 ARM-3100 ARM-3101 SBM 15 ARM-30W ARM-30J ARM-30F-XL ARM-3024-XL ARM-3025-XL ARM-3062-XL 9S Pro

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260276 · Shenzhen AOJ Medical Technology Co., Ltd. · Cardiovascular device
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Apr 2026
Decision
62d
Days
Class 2
Risk

K260276 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor Models: ARM-30C+. 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 1, 2026 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen AOJ Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K260276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2026
Decision Date April 01, 2026
Days to Decision 62 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K260276.
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