IntelliVue Patient Monitor 6100 (6100) +2 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250453 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IntelliVue Patient Monitor 6100, 6300, and 6500 are physiological patient monitors designed for continuous, non-invasive monitoring of vital signs. These devices detect and alert for arrhythmias, providing real-time patient data such as ECG, blood pressure, SpO₂, and respiratory rate to support clinical decision-making in acute and critical care settings.
These monitors are intended for use in clinical environments and are supplied as reusable medical devices. They comply with FDA 510(k) and MDR regulatory requirements, with the 6100, 6300, and 6500 models classified under device class 2. Each model is equipped for integration into hospital networks and is intended for single-patient use per session, though reprocessing procedures must adhere to manufacturer guidelines. No MRI safety information or specific sterility claims are provided in the data.
Frequently asked questions
Are the IntelliVue Patient Monitors 6100, 6300, and 6500 designed for single-patient use, or can they be reused across multiple patients?
The IntelliVue Patient Monitors 6100, 6300, and 6500 are intended for single-patient use per session, though they are reusable devices. Reprocessing must follow the manufacturer’s guidelines to ensure safety and compliance with regulatory requirements. Since they are not sterile by design, they are not intended for direct patient contact without proper cleaning and sterilization between uses.
What types of vital signs can the IntelliVue Patient Monitors detect and display in real time?
The monitors continuously and non-invasively measure ECG, blood pressure, SpO₂ (oxygen saturation), and respiratory rate, along with arrhythmia detection and alerts. These features support clinical decision-making in acute and critical care settings by providing real-time patient data.
How are these monitors integrated into hospital workflows, and do they require any specific infrastructure?
The IntelliVue Patient Monitors 6100, 6300, and 6500 are designed for network integration, allowing them to connect to hospital systems for centralized monitoring and data management. While they do not specify MRI compatibility, their connectivity suggests compatibility with standard clinical IT infrastructure, though setup may require IT support.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
The monitors have undergone FDA 510(k) clearance and comply with MDR (Medical Device Regulation) requirements, with all three models classified as Class II devices. This classification means they are subject to stricter controls than Class I but do not require the same level of scrutiny as Class III devices. Their regulatory status ensures they meet safety and performance standards for use in acute and critical care environments.
Are there any special handling or storage requirements for these reusable monitors?
While the data does not specify sterility claims or MRI safety, the monitors are reusable and must be properly cleaned and maintained between uses to prevent cross-contamination. Storage should follow manufacturer guidelines to preserve functionality, though no specific environmental conditions (e.g., temperature, humidity) are detailed in the provided data. Always refer to the manufacturer’s instructions for reprocessing and storage.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250453 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
Sources (2)
- FDA 510(k) K250453 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026