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FDA 510(k)

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

K-Number: K251745 · 2025-12-16

ApplicantBaxter Healthcare Corporation
Decision Date2025-12-16
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2025-12-16 under approval number K251745. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)?

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K251745.

When was Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) approved by the FDA?

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) received FDA 510(k) clearance on 2025-12-16, under approval number K251745.

What company makes Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)?

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)?

The FDA product code for Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) is DXQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

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Related Devices (Code: DXQ)

K160530Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure CuffShenzhen Med-Link Electronics Tech Co., Ltd. K161035Medline Singe Patient Use Blood Pressure CuffMedline Industries, Inc. K152006Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. K153251Tenso TS-101S and TS-101D Disposable Blood Pressure CuffNingbo Free Trade Zone Tenso Medical Instruments Co., Ltd. K171889Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. K173044Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffNingbo Albert Novosino Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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