Welch Allyn FlexiPort Blood Pressure Cuffs are intended to be used for patient health screening assessment to determine patient's systolic/diastolic blood pressure when used in conjunction with non-automated and automated sphygmomanometers.

Welch Allyn FlexiPort Blood Pressure Cuffs are noninvasive blood pressure cuffs intended for use in conjunction with non-automated and automated sphygmomanometers to determine blood pressure in pediatric through adult patients.

FlexiPort Blood Pressure Cuffs are intended to be used by a clinically trained medical professional.

Device Description

Welch Allyn FlexiPort Blood Pressure Cuffs product line consists of Reuse, Soft & Vinyl Blood Pressure Cuffs used for patient health screening assessment to determine the patient's systolic/diastolic blood pressure when used in conjunction with non-automated and automated sphygmomanometers. This product line was previously cleared under 510(k) premarket notification K070060 on December 18, 2007.

Welch Allyn FlexiPort Blood Pressure Cuffs are designed with the FlexiPort, a port connector which can rotate 360 degrees to reduce tube kinking and a standardized connector for quick exchange of tubing and fittings that interface with manual or electronic sphygmomanometers. The FlexiPort feature allows the interface tubing (either one- or two-tube) to remain with the blood pressure measurement device, while the cuff can be easily removed and moved from one location to another. The cuff can then be used universally within a facility on multiple devices.

The following are the types of FlexiPort Blood Pressure Cuffs available with the FlexiPort feature.
a. Welch Allyn FlexiPort Reusable Blood Pressure Cuffs (also referred as Reuse Blood Pressure Cuffs).
b. Welch Allyn FlexiPort Soft Blood Pressure Cuffs (also referred as Soft Blood Pressure Cuffs).
c. Welch Allyn FlexiPort Vinyl Blood Pressure Cuffs (also referred as Vinyl Blood Pressure Cuffs).

AI/ML Overview

N/A

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

December 16, 2025

Baxter Healthcare Corporation
Aravinda Yellina
Regulatory Affairs Senior Specialist
One Baxter Parkway
Deerfield, Illinois 60015

Re: K251745
Trade/Device Name: Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
Regulation Number: 21 CFR 870.1120
Regulation Name: Blood Pressure Cuff
Regulatory Class: Class II
Product Code: DXQ
Dated: November 7, 2025
Received: November 14, 2025

Dear Aravinda Yellina:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K251745 - Aravinda Yellina Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K251745 - Aravinda Yellina Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S

LCDR Stephen Browning
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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K251745

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K251745

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

Indications for Use (Describe)
Welch Allyn FlexiPort Blood Pressure Cuffs are intended to be used for patient health screening assessment to determine patient's systolic/diastolic blood pressure when used in conjunction with non-automated and automated sphygmomanometers.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Section 8-B. 510(K) Summary

OWNER:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015

CONTACT PERSON:
Aravinda Yellina
Senior Specialist, Regulatory Affairs
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
Classification Panel: 74 Cardiovascular
Regulation Number: 21 CFR 870.1120
Regulation Name: Blood Pressure Cuff
Regulatory Class: Class II
Product Code: DXQ

Table 1. Model number for FlexiPort Blood Pressure Cuffs

Model Number	Name
901043	BLOOD PRESSURE CUFFS, REUSABLE
901044	BLOOD PRESSURE CUFFS, SOFT & VINYL

Predicate Device

Table 2. Predicate Device

Device	Company	Predicate 510(k)	Clearance Date
Welch Allyn FlexiPort Blood Pressure Cuff	Welch Allyn, Inc. (a subsidiary of Baxter Healthcare Corporation)	K070060	December 18, 2007

K251745 Page 1 of 11

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DESCRIPTION OF THE DEVICE:

The following are the types of FlexiPort Blood Pressure Cuffs available with the FlexiPort feature.

a. Welch Allyn FlexiPort Reusable Blood Pressure Cuffs (also referred as Reuse Blood Pressure Cuffs).

b. Welch Allyn FlexiPort Soft Blood Pressure Cuffs (also referred as Soft Blood Pressure Cuffs).

Welch Allyn FlexiPort Vinyl Blood Pressure Cuffs (also referred as Vinyl Blood Pressure Cuffs).

INTENDED USE:

FlexiPort Blood Pressure Cuffs are intended to be used by a clinically trained medical professional.

INDICATIONS FOR USE:

K251745 Page 2 of 11

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DEVICE COMPARISON TABLE

The device comparison Table 3 outlining the differences in the device features between the proposed device (subject to this premarket notification) and the device that was submitted under K070060.

K251745 Page 3 of 11