Trilogy 200 Ventilator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093416 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 Trilogy 200 Ventilator is a continuous, facility-use mechanical ventilator designed to provide respiratory support for patients across pediatric to adult sizes. It delivers both continuous and intermittent ventilatory assistance, supporting spontaneous breathing and controlled ventilation modes for critical care settings.
This device is intended for use in hospital, home, and alternative care environments, where it must be operated by trained personnel. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDD regulatory standards. The Trilogy 200 is classified as a Class II device under the FDA’s regulation number 868.5895, with no third-party involvement in its distribution. Sterility is not specified, and MRI safety data is not provided.
Frequently asked questions
What environments is the Trilogy 200 Ventilator designed for, and who should operate it?
The Trilogy 200 Ventilator is intended for use in hospital, home, and alternative care settings. It is designed to provide respiratory support for patients ranging from pediatric to adult sizes, delivering both continuous and intermittent ventilatory assistance. Due to its complexity, it must be operated by trained personnel familiar with critical care ventilation.
Is the Trilogy 200 Ventilator a single-use or reusable device, and what does that mean for maintenance?
The Trilogy 200 Ventilator is a reusable medical device, meaning it is built for repeated use in clinical settings. This implies that it requires regular cleaning, disinfection, and maintenance as outlined in the manufacturer’s instructions to ensure safety, functionality, and compliance with regulatory standards.
What regulatory pathways has the Trilogy 200 Ventilator followed, and what does that indicate about its approval status?
The Trilogy 200 Ventilator has followed the FDA’s 510(k) pathway and adheres to the Medical Device Directive (MDD) in Europe. It is classified as a Class II device under FDA regulation number 868.5895, indicating it has been determined to be substantially equivalent to a predicate device and meets the necessary safety and performance requirements without third-party distribution involvement.
Does the Trilogy 200 Ventilator come with any specific sterility guarantees, and how should it be stored?
The Trilogy 200 Ventilator does not specify sterility as part of its design or labeling, meaning it is not pre-sterilized for single-use. Since it is reusable, proper cleaning, disinfection, and storage procedures must be followed to maintain hygiene and functionality. Storage should adhere to the manufacturer’s guidelines to prevent contamination and ensure longevity.
What patient sizes does the Trilogy 200 Ventilator support, and how does it accommodate different ventilation needs?
The Trilogy 200 Ventilator is designed to support patients across the pediatric to adult size spectrum, offering both spontaneous breathing assistance and controlled ventilation modes. This versatility allows it to adapt to various clinical scenarios, including critical care settings where patients may require different levels of respiratory support, such as assisted or fully controlled ventilation.
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: Respironics Trilogy 200 Technical Information - ManualsLib, PHILIPS Respironics Trilogy 200 - Manual, User manual, Respironics Trilogy 200 Manuals | ManualsLib, PDF Philips Respironics Trilogy 200 Portable Ventilator
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K093416 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (2)
- FDA 510(k) K093416 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026