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SERVO-U Ventilator System, SERVO-n Ventilator System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K151814

by Maquet Critical Care AB

Identifiers

510(k) Number
K151814 FDA 510(k)
FDA Product Code
CBK 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-U and SERVO-n Ventilator Systems are continuous-use, facility-based ventilators designed to provide mechanical ventilation for patients in critical care settings. These devices deliver controlled or assisted ventilation, including pressure support, volume control, and advanced respiratory modes to manage acute and chronic respiratory failure, often in intensive care units (ICUs) or operating rooms.

These ventilators are intended for use in hospital environments and are supplied as reusable medical devices. They are regulated under the FDA’s 510(k) pathway as substantially equivalent to predicate devices, with clearance under the classification for ventilators (Class II). The systems require proper maintenance, calibration, and adherence to manufacturer guidelines to ensure safe operation. They are not single-use and must be cleaned, disinfected, and serviced according to established protocols.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Maquet Critical Care AB

Sources (2)

  • FDA 510(k) K151814 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026