Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113798 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
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 Infinity Acute Care System, including the Infinity MCable-Masimo Rainbow Set, is a physiological patient monitor designed for continuous monitoring of vital signs in acute care settings. It incorporates arrhythmia detection and alarm capabilities, enabling real-time assessment of cardiac rhythms and other critical parameters to support clinical decision-making in high-acuity environments.
This system is intended for use in hospital intensive care units, emergency departments, and other acute care settings where continuous patient monitoring is required. The Infinity MCable-Masimo Rainbow Set is supplied as a reusable component, compatible with the Infinity Acute Care System for non-invasive monitoring. The device adheres to FDA 510(k) and MDR regulatory standards, with a classification as a Class II medical device under the regulation number 870.1025. It is not intended for MRI use and must be stored according to manufacturer guidelines to maintain functionality and sterility.
Frequently asked questions
What clinical environments is the Infinity Acute Care System designed for, and why is this important for continuous monitoring?
The Infinity Acute Care System is specifically designed for high-acuity settings like hospital intensive care units (ICUs) and emergency departments, where patients require continuous and real-time monitoring. This is important because these environments demand immediate assessment of critical parameters such as cardiac rhythms, arrhythmias, and other vital signs to support rapid clinical decision-making and patient stability.
Is the Infinity MCable-Masimo Rainbow Set reusable or single-use, and how does this affect its use in clinical settings?
The Infinity MCable-Masimo Rainbow Set is a reusable component, designed to be compatible with the Infinity Acute Care System for non-invasive monitoring. This makes it cost-effective for clinical settings, as it can be cleaned, sterilized, and reused across multiple patients, provided proper maintenance protocols are followed. Reusability also reduces waste, aligning with sustainable clinical practices.
What regulatory pathways has the Infinity Acute Care System followed, and what does this classification mean for its use?
The Infinity Acute Care System has undergone FDA 510(k) clearance and adheres to the EU’s Medical Device Regulation (MDR), classifying it as a Class II device under regulation number 870.1025. This classification indicates it is subject to stricter controls than Class I devices but does not require the same rigorous oversight as Class III devices. Clinically, this means it has been evaluated for safety and performance in acute care settings while balancing regulatory requirements with practical implementation.
Are there any storage guidelines for the Infinity Acute Care System that clinicians should be aware of?
Yes, the Infinity Acute Care System must be stored according to the manufacturer’s guidelines to maintain both functionality and sterility. While the data does not specify exact storage conditions, adherence to these guidelines ensures the device remains reliable for continuous monitoring in acute care settings. Proper storage is critical to prevent contamination, damage, or degradation of performance over time.
Can the Infinity Acute Care System be used in MRI environments, and if not, what alternatives should clinicians consider?
No, the Infinity Acute Care System is explicitly not intended for MRI use. Clinicians should avoid using it in magnetic resonance imaging environments, as the device may be incompatible with MRI fields, potentially causing interference or damage. For MRI-compatible monitoring, alternative devices specifically designed for MRI-safe environments should be selected instead.
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: Be Infinity – Learn Freedom. Live Infinity.
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 | K113798 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA 510(k) K113798 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 18, 2026