Cleared Traditional

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

K251745 · Baxter Healthcare Corporation · Cardiovascular
Dec 2025
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K251745 is an FDA 510(k) clearance for the Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs), a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on December 16, 2025, 193 days after receiving the submission on June 6, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number K251745 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2025
Decision Date December 16, 2025
Days to Decision 193 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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