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Avita Bpm1 Series (wrist Type) Blood Pressure Meter (or Monitor)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K030230

by Avita Corporation

Identifiers

510(k) Number
K030230 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

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)

The Avita BPM1 Series is a wrist-type blood pressure meter, classified as a device for measuring and monitoring blood pressure. It falls under the nomenclature for non-invasive blood pressure monitors, designed to provide accurate readings of systolic and diastolic pressure via a cuff-based measurement system applied to the wrist.

This device is intended for single-use or reusable clinical and home-use settings, depending on the model variant. Supplied in sterile or non-sterile configurations as specified, it complies with FDA 510(k) clearance (K030230) under the Traditional pathway, as well as EU MDR and MDD authorisations. Storage and handling follow manufacturer guidelines to ensure device integrity, with no specific MRI safety restrictions noted.

Frequently asked questions

What types of settings can the Avita BPM1 Series be used in, and how is it differentiated between single-use and reusable models?

The Avita BPM1 Series is designed for both clinical and home-use settings. The device is available in either single-use or reusable configurations, allowing flexibility depending on the environment and infection control protocols. Single-use models are ideal for clinical settings where hygiene is critical, while reusable models are suited for home monitoring where durability and repeated use are preferred.

Are there different sterility options for the Avita BPM1 Series, and how should they be handled?

Yes, the Avita BPM1 Series is supplied in either sterile or non-sterile configurations. Sterile versions are intended for clinical use to minimize infection risk, while non-sterile versions are typically used in home settings. Proper storage and handling per manufacturer guidelines are essential to maintain device integrity, particularly for sterile models.

What regulatory pathways has the Avita BPM1 Series gone through, and which advisory committee was involved?

The Avita BPM1 Series received FDA clearance under the Traditional 510(k) pathway (K030230) and was deemed substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee. Additionally, it complies with EU MDR and MDD authorizations, ensuring it meets both U.S. and European regulatory standards.

Does the Avita BPM1 Series have any restrictions on use in environments with MRI machines?

The Avita BPM1 Series does not have any specific MRI safety restrictions noted in its documentation. However, since it is a wrist-type blood pressure monitor, it should not be used in close proximity to MRI equipment during active scans, as the device itself may not be MRI-safe and could interfere with imaging or pose risks in a magnetic field.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Avita Corporation

Sources (2)

  • FDA 510(k) K030230 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026