Identifiers
- 510(k) Number
- K081572 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Smartsigns MiniPulse MP1 is a non-invasive pulse oximeter designed for continuous monitoring of peripheral capillary oxygen saturation (SpO₂) and pulse rate. It is classified as a cardiovascular monitoring device, providing real-time data to assess patient oxygenation and circulatory status in clinical settings.
This device is supplied as a reusable medical instrument, intended for use in hospital wards, intensive care units, and other clinical environments requiring continuous patient monitoring. It operates without MRI compatibility restrictions and is authorised for use following FDA 510(k) clearance under the traditional review pathway. Sterilisation and maintenance procedures must adhere to manufacturer guidelines to ensure accurate and reliable performance.
Frequently asked questions
Is the Smartsigns MiniPulse reusable or single-use, and what does that mean for my clinical workflow?
The Smartsigns MiniPulse is designed as a reusable medical device, meaning it is intended for repeated use across multiple patients after proper sterilization and maintenance. This makes it cost-effective for continuous monitoring in settings like hospital wards or ICUs, but it requires adherence to manufacturer guidelines for cleaning, disinfection, and sterilization to ensure accuracy and reliability between uses. Reusability also means it can be integrated into existing monitoring systems without the need for disposable replacements.
How does the Smartsigns MiniPulse differ from other pulse oximeters in terms of its intended clinical use?
The MiniPulse is specifically designed for continuous monitoring of peripheral capillary oxygen saturation (SpO₂) and pulse rate in clinical environments like hospital wards and intensive care units. Unlike some pulse oximeters that may be used intermittently or for spot-checking, this device is built for real-time assessment of a patient’s oxygenation and circulatory status, making it ideal for scenarios where ongoing vital sign tracking is critical. Its non-invasive design ensures it can be used without disrupting patient care.
What should I consider when storing the Smartsigns MiniPulse to maintain its performance?
While the provided data doesn’t specify exact storage conditions, reusable medical devices like the MiniPulse generally require protection from physical damage, extreme temperatures, and contamination. Since it’s intended for clinical use, it should be stored in a clean, dry environment—preferably in its original packaging or a designated storage case—when not in use. Always follow the manufacturer’s instructions for long-term storage to preserve calibration, sensor integrity, and overall functionality, especially if it’s part of a critical monitoring system.
Does the Smartsigns MiniPulse have any restrictions on where it can be used in a hospital?
The MiniPulse is not MRI-compatible, meaning it should not be used in areas where MRI scans are performed or near strong magnetic fields, as this could affect its performance or pose safety risks. However, it is designed for general clinical use in hospital wards, intensive care units, and other non-MRI environments where continuous monitoring of SpO₂ and pulse rate is required. Always verify its placement in compliance with hospital protocols for electromagnetic interference.
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: Huntleigh Smartsigns MiniPulse Instructions For Use Manual, Huntleigh Smartsigns MiniPulse: AI Chat & PDF Download | Manualzz, Huntleigh Smartsigns MiniPulse Manuals | ManualsLib, Diagnostic Devices & Monitoring Solutions Huntleigh Healthcare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081572 | Class II | Active |
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Manufacturer
- Manufacturer
- Huntleigh Healthcare , Ltd.
Sources (1)
- FDA 510(k) K081572 24 fields · synced Oct 6, 2026