Servo-air Lite Ventilator System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230173 FDA 510(k)
- FDA Product Code
- MNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5895 FDA 510(k)
- Regulation Number
- 868.5895 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Servo-air Lite Ventilator System is a turbine-driven mechanical ventilator designed to assist or control patient breathing. It delivers a predetermined oxygen concentration in the breathing gas, serving adult, pediatric, and neonatal patients. The device is classified as a Class II medical device under FDA regulations, intended for use in critical care settings where reliable respiratory support is required. Its turbine-driven mechanism eliminates the need for external compressed air sources, enhancing portability and flexibility in clinical environments.
This ventilator system is supplied as a reusable medical device, requiring proper cleaning, disinfection, and maintenance per manufacturer guidelines. It is intended for use in hospital settings, including operating rooms, intensive care units, and emergency departments, where continuous respiratory support is necessary. The device includes battery backup for transport and operation in areas without immediate access to power. Regulatory authorisation includes FDA 510(k) clearance under the advisory committee for Anesthesiology, with specific product codes and registration numbers listed in the submission records.
Frequently asked questions
What patient populations is the Servo-air Lite Ventilator System designed for?
The Servo-air Lite Ventilator System is specifically designed to provide respiratory support for adult, pediatric, and neonatal patients in critical care settings. Its turbine-driven mechanism ensures consistent performance across these diverse patient groups, making it versatile for hospitals, operating rooms, intensive care units, and emergency departments where precise ventilation is required.
How is the Servo-air Lite Ventilator System supplied and maintained?
The Servo-air Lite Ventilator System is supplied as a reusable medical device. After each use, it must undergo thorough cleaning, disinfection, and maintenance following the manufacturer’s guidelines to ensure safety, functionality, and compliance with clinical standards. Proper upkeep is essential for reliable performance and longevity in high-demand environments.
Does the Servo-air Lite Ventilator System require external compressed air?
No, the Servo-air Lite Ventilator System uses a turbine-driven mechanism, eliminating the need for external compressed air sources. This design enhances portability and flexibility, allowing clinicians to operate the device in various settings—including areas without immediate access to compressed air—while maintaining consistent oxygen delivery and ventilation support.
What power options are available for the Servo-air Lite Ventilator System?
The Servo-air Lite Ventilator System includes a built-in battery backup, enabling continuous operation during transport or in locations where power may be unreliable. This feature ensures uninterrupted respiratory support for patients, particularly in emergency or off-grid scenarios where electrical access is limited.
What regulatory approvals does the Servo-air Lite Ventilator System hold?
The Servo-air Lite Ventilator System holds FDA 510(k) clearance under the Anesthesiology advisory committee, confirming its substantial equivalence to a predicate device. This clearance allows its use in U.S. clinical settings for respiratory support in critical care, including operating rooms, ICUs, and emergency departments, where reliable ventilation is required.
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: Getinge Servo-air® Lite, Servo-air Lite Ventilator System (K230173) — FDA 510 (k) | Innolitics, PDF Servo-air & Servo-air Lite ventilators - getinge.com, MAQUET SERVO-AIR USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230173 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
Sources (1)
- FDA 510(k) K230173 24 fields · synced Oct 5, 2026