Identifiers
- 510(k) Number
- K014122 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 HL168E is a non-invasive blood pressure measurement system, designed to accurately measure and monitor blood pressure without penetrating the skin. Classified under product code DXN, it falls within the category of cardiovascular measurement devices, providing essential diagnostic data for clinical assessment.
This device is intended for single-use or reusable applications in clinical or home settings, adhering to FDA 510(k) clearance under Special Controls for non-invasive blood pressure measurement. Supplied sterile or non-sterile as specified, it operates under regulatory compliance with 21 CFR 870.1130 and requires proper storage to maintain performance. Authorized for use in the United States, it was cleared by the FDA in January 2002.
Frequently asked questions
What types of settings can the HL168E be used in, and how is it intended to be used in those settings?
The HL168E is designed for use in both clinical and home settings. It is a non-invasive blood pressure measurement system, meaning it measures blood pressure without requiring needles or skin penetration. This makes it suitable for repeated monitoring in environments like hospitals, doctor’s offices, or patient homes, where convenience and ease of use are important.
Is the HL168E meant to be used only once, or can it be reused? If reusable, what care instructions should be followed?
The HL168E is intended for either single-use or reusable applications, depending on the specific configuration or instructions provided by the manufacturer. If reused, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure accuracy and hygiene. Since it is classified under product code DXN for cardiovascular measurement, proper sterilization (if applicable) and storage are critical to maintaining performance and compliance with 21 CFR 870.1130.
How should the HL168E be stored to ensure it remains accurate and functional over time?
The HL168E requires proper storage to maintain its performance and accuracy. While the exact storage conditions are not detailed here, typical non-invasive blood pressure devices should be kept in a clean, dry environment away from extreme temperatures or direct sunlight. If the device is supplied sterile, it must be stored according to the manufacturer’s instructions to preserve sterility until use. Always refer to the included documentation for specific storage guidelines.
What regulatory pathway did the HL168E follow to gain market authorization in the U.S., and what does that mean for its use?
The HL168E was cleared by the FDA through a 510(k) premarket notification process, specifically under Special Controls for non-invasive blood pressure measurement devices (product code DXN). This means the manufacturer demonstrated that their device is substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness. Clinicians and users can rely on this clearance as evidence that the device adheres to U.S. regulatory standards for cardiovascular measurement.
Can the HL168E be used internationally, or is it only authorized for the U.S. market?
The HL168E is explicitly authorized for use only in the United States, as indicated by its FDA 510(k) clearance. While the device may comply with international standards, its regulatory approval is limited to U.S. markets. For use outside the U.S., additional local regulatory approvals or certifications would be required, depending on the country’s healthcare regulations.
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: K014122 - HL168E | FDA 510 (k) | Health & Life Co., Ltd., HL168E (K014122) — FDA 510 (k) | Innolitics, Hl168e 510 (k) FDA Premarket Notification K014122 HEALTH & LIFE CO., LTD., HL168E (K014122) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K014122 | Class II | Active |
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Manufacturer
- Manufacturer
- Health & Life Co., Ltd.
Sources (1)
- FDA 510(k) K014122 24 fields · synced Oct 6, 2026