510(k) K181166 ยท CBK Ventilator, Continuous, Facility Use
Trilogy Evo
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jul 18, 2019 |
| Received | May 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2026 | Philips Respironics, Inc. Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. Open, Classified |
CBK | None listed |
| Apr 2, 2026 | Philips Respironics, Inc. Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. Open, Classified |
CBK | None listed |
| Apr 2, 2026 | Philips Respironics, Inc. Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. Open, Classified |
CBK | None listed |
| Mar 26, 2026 | Philips Respironics, Inc. Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. Open, Classified |
CBK | None listed |
| Nov 13, 2024 | Philips Respironics, Inc. Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN Open, Classified |
CBK | None listed |
| Nov 13, 2024 | Philips Respironics, Inc. Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB Open, Classified |
CBK | None listed |
| Nov 13, 2024 | Philips Respironics, Inc. Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR Open, Classified |
CBK | None listed |
| Apr 17, 2024 | Philips Respironics, Inc. Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Open, Classified |
CBK | None listed |
| Apr 17, 2024 | Philips Respironics, Inc. Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Open, Classified |
CBK | None listed |
| Apr 17, 2024 | Philips Respironics, Inc. LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Open, Classified |
CBK | None listed |
| Apr 17, 2024 | Philips Respironics, Inc. Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Open, Classified |
CBK | None listed |
| Apr 17, 2024 | Philips Respironics, Inc. Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Open, Classified |
CBK | None listed |
| Jan 4, 2024 | Philips Respironics, Inc. Trilogy Evo and Trilogy Evo O2
Material Numbers BL2110X15B
BR2110X18B
CA2110X12B
DE2100X13B
DE2110X13B
DS2100X11B
DS2110X11B
EE2100X15B
EE2110X15B
ES2100X15B
ES2110X15B
EU2100X15B
EU2100X19
EU2110X15B Open, Classified |
CBK | None listed |
| Jul 7, 2023 | Philips Respironics, Inc. Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use Open, Classified |
CBK | None listed |
| Jun 2, 2023 | Philips Respironics, Inc. Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2 Open, Classified |
CBK | None listed |
| Jun 2, 2023 | Philips Respironics, Inc. Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B Open, Classified |
CBK | None listed |
| Jun 2, 2023 | Philips Respironics, Inc. Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B Open, Classified |
CBK | None listed |
| Apr 3, 2023 | Philips Respironics, Inc. Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR210 Open, Classified |
CBK | None listed |
| Apr 3, 2023 | Philips Respironics, Inc. Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B Open, Classified |
CBK | None listed |
| Jan 22, 2022 | Philips Respironics, Inc. Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257
The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individua Open, Classified |
CBK | None listed |
| Jul 26, 2021 | Philips Respironics, Inc. Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR211 Open, Classified |
NOU | None listed |
| Jul 26, 2021 | Philips Respironics, Inc. Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, R Open, Classified |
NOU | None listed |
| Jul 26, 2021 | Philips Respironics, Inc. Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B Open, Classified |
NOU | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, International, Model Number IN2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alar Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, EU - Model Number: EU2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Garbin EVO Ventilator, Linde - Model Number: LD2110X23B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm S Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, an Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alar Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, France - Model Number: FR2110X14B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, recor Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and a Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alar Terminated |
CBK | None listed |
| Feb 15, 2020 | Philips Respironics, Inc. LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B
Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm Sp Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.