Cleared Traditional

AViTA Arm Type Blood Pressure Monitor Cuff

K250765 · Avita Corporation · Cardiovascular
Sep 2025
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K250765 is an FDA 510(k) clearance for the AViTA Arm Type Blood Pressure Monitor Cuff, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Avita Corporation (New Taipei, TW). The FDA issued a Cleared decision on September 3, 2025, 174 days after receiving the submission on March 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number K250765 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2025
Decision Date September 03, 2025
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXQ — Blood Pressure Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.

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