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Hl168f

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020766

by Health & Life Co., Ltd.

Identifiers

510(k) Number
K020766 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 HL168F is a non-invasive blood pressure measurement system designed for clinical use. Classified under product code DXN, it falls within the category of cardiovascular measurement devices, providing accurate readings of systolic and diastolic blood pressure without penetrating the skin. Its primary function aligns with regulatory definitions for non-invasive blood pressure monitors, ensuring compliance with safety and performance standards for patient assessment.

This device is intended for single-use or reusable applications in clinical settings, adhering to FDA 510(k) clearance under Special Controls for Class II devices. Supplied sterile or non-sterile based on manufacturer specifications, it requires proper storage and handling to maintain functionality. Authorized under 21 CFR 870.1130, the HL168F is regulated for cardiovascular measurement, with no explicit MRI safety or size variations noted in available data.

Frequently asked questions

What is the HL168F used for in clinical settings?

The HL168F is a non-invasive blood pressure measurement system designed to provide accurate readings of systolic and diastolic blood pressure. It is intended for clinical use, allowing healthcare professionals to assess cardiovascular health without the need for invasive procedures, such as skin penetration. This aligns with regulatory standards for non-invasive blood pressure monitors, ensuring reliable patient assessment.

Is the HL168F intended for single-use or reusable applications?

The HL168F is designed for flexibility in clinical settings, allowing for either single-use or reusable applications. The manufacturer specifies whether each unit is supplied sterile or non-sterile, so proper handling and storage instructions must be followed to maintain functionality and compliance with clinical protocols. Always refer to the device’s packaging or instructions for use to determine its intended use cycle.

How is the sterility of the HL168F determined?

The sterility of the HL168F depends on the specific unit purchased, as it can be supplied either sterile or non-sterile based on manufacturer specifications. Sterile units are intended for direct patient contact without additional reprocessing, while non-sterile units may require cleaning and disinfection before reuse. Check the packaging or consult the manufacturer’s guidelines to confirm sterility status.

What regulatory pathway does the HL168F follow?

The HL168F is regulated under the FDA’s 510(k) clearance process, classified as a Class II device under Special Controls. It falls under product code DXN for cardiovascular measurement devices and is authorized under 21 CFR 870.1130. The device was determined to be substantially equivalent to a predicate, ensuring compliance with safety and performance standards for non-invasive blood pressure monitoring.

Are there variations in size or MRI safety considerations for the HL168F?

Based on the available data, the HL168F does not have explicit size variations or MRI safety information documented. It is designed as a standard non-invasive blood pressure monitor for general clinical use. For MRI compatibility or specific size requirements, verify with the manufacturer or consult the device’s technical documentation, as these details may not be fully captured in regulatory filings.

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: K020766 - HL168F | FDA 510 (k) | Health & Life Co., Ltd., HL168F (K020766) — FDA 510 (k) | Innolitics, Hl168f - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Health & Life Co., Ltd.

Sources (1)

  • FDA 510(k) K020766 24 fields · synced Oct 6, 2026