Full Automatic (NIBP) Blood Pressure Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190507 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)
This device is a Noninvasive Blood Pressure Measurement System (per 21 CFR 870.1130), designed to automatically measure human systolic and diastolic blood pressure and heart rate using the oscillometric method. It operates by inflating a cuff around the upper arm to occlude arterial flow, then detecting pressure fluctuations to determine blood pressure values. The results are displayed on an LCD panel for immediate reading. The monitor adheres to FDA-recognized standards for noninvasive blood pressure measurement.
The Full Automatic (NIBP) Blood Pressure Monitor HL858DK is intended for single-use or reusable clinical settings, depending on manufacturer guidelines. It is not specified as MRI-safe or sterile at point of use but may require cleaning or sterilization procedures as outlined in the manufacturer’s instructions. The device is authorized under FDA 510(k) clearance (K190507) and falls under the Cardiovascular (CV) advisory committee classification. Compliance with regulatory requirements ensures its use in accredited healthcare environments for routine blood pressure assessment.
Frequently asked questions
What is the HL858DK Automatic NIBP Blood Pressure Monitor used for?
The HL858DK is a Noninvasive Blood Pressure Measurement System designed to automatically measure human systolic and diastolic blood pressure and heart rate using the oscillometric method. It inflates an arm cuff to temporarily block arterial flow, then detects pressure fluctuations to calculate accurate readings. This makes it ideal for routine clinical assessments in healthcare settings.
Is the HL858DK intended for single-use or reusable applications?
The HL858DK can be used in either single-use or reusable clinical settings, depending on the manufacturer’s guidelines. If reused, proper cleaning and sterilization procedures must follow the manufacturer’s instructions to ensure hygiene and device integrity. Always verify usage instructions before implementation.
Does the HL858DK come sterile at point of use?
The HL858DK is not specified as sterile at point of use. If sterilization is required, it must be performed according to the manufacturer’s instructions. For single-use applications, ensure proper disposal protocols are followed to maintain infection control standards.
What regulatory approval does the HL858DK hold?
The HL858DK Automatic NIBP Blood Pressure Monitor holds FDA 510(k) clearance under the classification of Cardiovascular (CV) advisory committee. The clearance number is K190507, and it is determined to be substantially equivalent to a predicate device. This ensures compliance with U.S. regulatory standards for noninvasive blood pressure measurement.
How are the blood pressure readings displayed on the HL858DK?
The HL858DK displays measured systolic and diastolic blood pressure values, along with heart rate, on an integrated LCD panel. This allows immediate visual confirmation of results for clinicians or patients during use.
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: Full Automatic (NIBP) Blood Pressure Monitor by Health & Life Co. Ltd ..., Full Automatic(NIBP) Blood Pressure Monitor (K200521) — FDA 510(k ..., Full Automatic(NIBP) Blood Pressure Monitor (K180240) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190507 | Class II | Active |
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Manufacturer
- Manufacturer
- Health & Life Co., Ltd.
Sources (1)
- FDA 510(k) K190507 24 fields · synced Oct 5, 2026