Trilogy Evo
FDA 510(k) K181166 · Respironics, Inc.
510(k) numberK181166
Submission
- Device name
- Trilogy Evo
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- May 2, 2018
- Decision date
- July 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | 12/30/2024SE |
| K231313 | Therapy Mask 3100 NC/SPBZD · Special | 07/28/2023SE |
| K210844 | DreamWear Silicone Pillows MaskBZD · Traditional | 08/24/2021SE |
| K210386 | Magneto Nasal MaskBZD · Traditional | 07/12/2021SE |
| K202142 | Sleepware G3OLZ · Traditional | 10/29/2020SE |
| K201439 | Ventilator, Non-continuous (Respirator)BZD · Traditional | 09/25/2020SE |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced SystemBZD · Traditional | 07/10/2020SE |
| K183625 | SomnaPatchMNR · Traditional | 10/18/2019SE |
| K183226 | Care Orchestrator EssenceBZD · Traditional | 10/18/2019SE |
| K181170 | Trilogy Evo UniversalCBK · Traditional | 07/18/2019SE |
Questions and answers
When was Trilogy Evo cleared by the FDA?
Trilogy Evo (K181166) received a 510(k) decision of Substantially Equivalent on July 18, 2019, 442 days after the submission was received.
What is the product code of K181166?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.