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FlexiPort Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece)

by Welch Allyn, Inc.

510(k) K070060Ref REUSE-07-1TPE, VINYL-08-1MQ, SOFT-12L-1MQ, REUSE-08, SOFT-09-2MF, SOFT-07-2MQ, REUSE-13-2TPE, SOFT-10-2TPE, REUSE-10-1TPE, SOFT-09-2BV, SOFT-12-2TPE, REUSE-13-1TP, REUSE-11L-1TPE, SOFT-12L-2BVC, SOFT-09-2TP, SOFT-11L-2BVC, REUSE-11L-1HP, VINYL-11, VINYL-13-1MQ, SOFT-10-1HP, VINYL-09-1HP, REUSE-07, REUSE-11-1HPModel 901043, 901044

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K070060↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901043EY Basic UDI-DI Date18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00732094186970 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK070060 Date18 Dec 2007ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1568-2025 FDA Class II initiated 21 Mar 2025

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Full name
Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece)
Trade Name
FlexiPort EUDAMED
Welch Allyn, Inc. GUDID
Generic Name
Blood pressure cuff, reusable
Model / Ref / Catalog
901044, 901043, REUSE-07-1TPE, VINYL-08-1MQ, SOFT-12L-1MQ, REUSE-08, SOFT-09-2MF, SOFT-07-2MQ, REUSE-13-2TPE, SOFT-10-2TPE, REUSE-10-1TPE, SOFT-09-2BV, SOFT-12-2TPE, REUSE-13-1TP, REUSE-11L-1TPE, SOFT-12L-2BVC, SOFT-09-2TP, SOFT-11L-2BVC, REUSE-11L-1HP, VINYL-11, VINYL-13-1MQ, SOFT-10-1HP, VINYL-09-1HP, REUSE-07, REUSE-11-1HP, VINYL-13-1MQUNO, VINYL-11L-2BVCUNO, SOFT-09-2BVUNO, SOFT-12L-2BVCUNO, SOFT-10-2TPEUNO, SOFT-10-1HPUNO, VINYL-07-2BVUNO, VINYL-08-1MQUNO, SOFT-11L-2BVCUNO, SOFT-11-1TPEUNO, SOFT-12-2TPEUNO, SOFT-12L-1MQUNO, SOFT-07-2MQUNO, SOFT-09-2TPUNO, VINYL-09-1HPUNO, SOFT-09-2MFUNO, VINYL-11UNO, REUSE-11-1TPE
Description
CUFF VINYL THIGH 1-TUBE MQ
CUFF VINYL AD LONG 2-TUBE BVC
CUFF SOFT CHILD 2-TUBE BV
CUFF SOFT LG AD LONG 2-TUBE BVC
CUFF SOFT SM AD 2-TUBE TPE
CUFF SOFT SM AD 1-TUBE HP
CUFF VINYL INFANT 2-TUBE BV
CUFF VINYL SM CHILD 1-TUBE MQ
CUFF SOFT AD LONG 2-TUBE BVC
CUFF SOFT ADULT 1-TUBE TPE
CUFF SOFT LG AD 2-TUBE TPE
CUFF SOFT LG AD LONG 1-TUBE MQ
CUFF SOFT INFANT 2-TUBE MQ
CUFF SOFT CHILD 2-TUBE TP
CUFF VINYL CHILD 1-TUBE HP
CUFF SOFT CHILD 2-TUBE MF
CUFF WA VINYL ADULT
Primary DI / UDI-DI
00732094186970, 00732094066883, 00732094188615, 00732094187892, 00732094065657, 00732094069389, 00732094188417, 00732094069181, 00732094188523, 00732094187533, 00732094188189, 00732094067552, 00732094187977, 00732094067064, 00732094068924, 00732094187939, 00732094188851, 00732094188554, 00732094187465, 00732094067859, 00732094188608, 00732094187151, 00732094065404, 00732094187205, 00732094187588, 00732094188349, 00732094067361
Basic UDI-DI
0732094GMN901043EY, 0732094GMN901044F2
Direct Marketing DI
00732094069389
00732094187472
00732094187823
00732094068924
00732094188530
00732094188813
00732094065749
00732094188387
00732094067958
00732094187816
00732094067088
00732094188103
00732094187151
00732094186918
00732094187397
00732094067583
510(k) Number
FDA Product Code
DXQ
EMDN Code
Z12040180 General medicine diagnosis and monitoring instruments - hardware accessories
GMDN Term
Blood pressure cuff, reusable
Models / Variants
Device Class
Class I EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1120
EU market of registration
Ireland
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class I
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FlexiPort Blood Pressure Cuffs are one-piece inflatable devices designed for measuring arterial blood pressure in adults and pediatric patients. They conform to the nomenclature definition of a blood pressure cuff, a device used to apply controlled pressure to an extremity to assess circulatory function and detect hypertension or hypotension. The disposable and reusable variants provide consistent inflation and deflation for accurate readings, with a flexible bladder for conforming to arm circumference.

These cuffs are supplied sterile for single-use (disposable) or non-sterile for reuse (reusable), adhering to FDA 510(k) clearance under product code DXQ and EU MDR compliance. They are intended for use in clinical, home, and ambulatory settings, with the reusable version requiring cleaning and disinfection between patients. Both variants are non-MRI compatible and available in standard adult and pediatric sizes, as specified in the original submission. No additional regulatory approvals beyond the stated authorisations are implied.

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See all devices from Welch Allyn, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the key differences between the disposable and reusable FlexiPort blood pressure cuffs, and how should they be handled?

    The disposable FlexiPort cuff is sterile and intended for single-use only, making it ideal for clinical settings where infection control is critical. The reusable version, however, is non-sterile and must be cleaned and disinfected between uses to maintain hygiene. Both are one-piece inflatable cuffs designed for accurate blood pressure measurements in adults and pediatric patients, but the reusable model requires additional processing to ensure safe reuse.

  • Are these cuffs compatible with MRI machines, and what sizes are available?

    No, the FlexiPort blood pressure cuffs are explicitly labeled as non-MRI compatible, meaning they should not be used in or near MRI environments. They are available in standard adult and pediatric sizes, as outlined in the original submission, ensuring a proper fit for accurate blood pressure readings across different patient demographics.

  • How do I determine which size cuff to use for a patient, and where can I find additional guidance?

    The FlexiPort cuffs are designed with standard adult and pediatric sizes to accommodate varying arm circumferences. While the exact sizing chart isn’t provided here, the manufacturer’s instructions or accompanying documentation should specify the appropriate cuff size based on the patient’s arm circumference. Proper sizing is essential for accurate blood pressure measurements, as an ill-fitting cuff can lead to incorrect readings.

  • What regulatory pathways have these cuffs followed, and where were they reviewed?

    The FlexiPort blood pressure cuffs were cleared by the FDA under a 510(k) submission (K070060) and are also compliant with the EU Medical Device Regulation (MDR). The device was reviewed by the Cardiovascular (CV) Advisory Committee under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE). This means the cuffs were determined to be as safe and effective as legally marketed predicate devices.

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No