Cleared Traditional

K230649 - Arm Blood Pressure Monitor

K230649 is an FDA 510(k) clearance for Arm Blood Pressure Monitor, manufactured by Alicn Medical (Shenzhen), Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K230649 · Alicn Medical (Shenzhen), Inc. · Cardiovascular device
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Sep 2023
Decision
182d
Days
Class 2
Risk

K230649 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 Alicn Medical (Shenzhen), Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2023 after a review of 182 days - an extended review cycle.

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 Alicn Medical (Shenzhen), Inc. devices

FDA 510(k) Submission Details - K230649

510(k) Number K230649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2023
Decision Date September 07, 2023
Days to Decision 182 days
Submission Type Traditional
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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 K230649.
Arm Blood Pressure Monitor
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