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Welch Allyn 901123 Digital Blood Pressure Device

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K181832

by Guangdong Transtek Medical Electronics Co., Ltd

Identifiers

510(k) Number
K181832 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
Models / Variants
Transtek Blood Pressure Monitor FDA 510(k)EUDAMED
Welch Allyn 901123 Digital Blood Pressure Device FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a digital blood pressure monitor classified as an automatic blood pressure cuff (Nomenclature Authority: Medical Specialty Cardiovascular). It measures systolic and diastolic blood pressure and heart rate in patients aged three years and older, accommodating arm circumferences ranging from 15 cm to 55 cm. The device provides automated readings via an inflatable cuff and digital display, ensuring accurate vital sign assessment in clinical settings.

The Welch Allyn 901123 is supplied as a single-use or reusable device (sterility status not specified) and is intended for use in healthcare environments such as hospitals, clinics, or home monitoring. It complies with FDA 510(k) clearance (K181832) and MDR, with no third-party reprocessing required. Storage conditions and MRI safety are not detailed in the specifications. The device is regulated under Regulation Number 870.1130 and falls under Product Code DXN.

Frequently asked questions

What age group is the Welch Allyn 901123 Digital Blood Pressure Device designed for, and what size range of arm circumferences does it accommodate?

The Welch Allyn 901123 is designed for patients aged three years and older. It accommodates arm circumferences ranging from 15 cm to 55 cm, making it suitable for a broad range of adult and pediatric patients within that age group.

Is the Welch Allyn 901123 Digital Blood Pressure Device intended for single-use or reusable applications, and does it require third-party reprocessing?

The device is supplied as either single-use or reusable, though its sterility status is not explicitly specified. Importantly, the manufacturer states no third-party reprocessing is required, meaning if reusable, it must be cleaned and maintained by the facility itself.

What types of healthcare settings is the Welch Allyn 901123 Digital Blood Pressure Device intended for, and what vital signs does it measure?

The device is intended for use in healthcare environments such as hospitals, clinics, or even home monitoring. It measures systolic and diastolic blood pressure, as well as heart rate, providing automated readings via an inflatable cuff and digital display.

What regulatory pathways has the Welch Allyn 901123 Digital Blood Pressure Device followed, and what classification does it fall under?

The device has followed the FDA 510(k) clearance pathway with clearance number K181832, and it is also compliant with the EU Medical Device Regulation (MDR). It is classified under the FDA’s Product Code DXN and falls under the Cardiovascular advisory committee classification.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood ..., Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood ..., Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangdong Transtek Medical Electronics Co., Ltd
FDA Applicant
Guangdong Transtek Medical Electronics Co., Ltd.

Sources (2)

  • FDA 510(k) K181832 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026