# K181166: Trilogy Evo

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 18, 2019 after 442 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 36 (31 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K953930 (1996). 173 ancestors in all.
5 later devices descend from it; 4 cite it directly.
18 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111610: Trilogy Series Ventilator with Oximetry, Respironics, Inc. (2011) Summary page 4.
- K160481: Vivo 60, Breas Medical AB (2016) Summary page 4.
- K151252: Puritan Bennett 840 Series Ventilator System, Covidien LP (2016) Summary page 4.
- K162877: VOCSN Unified Respiratory System, Ventec Life Systems, Inc. (2017) Summary page 4.
- K121623: Bipap a 40 Ventilatory Support System, Respironics, Inc. (2012) Summary page 4.

## Most influential descendants
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own
- K233452: Vivo 45 LS (2025), 0 descendants of its own
- K241135: RESPOND (R) Ventilator (2024), 0 descendants of its own
- K240807: VM-2000 (2024), 0 descendants of its own

## Recalls of this device
- Mar 2, 2026 · Class I · Z-1647-2026: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Mar 2, 2026 · Class I · Z-1614-2026: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
- Mar 2, 2026 · Class I · Z-1648-2026: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Mar 2, 2026 · Class I · Z-1646-2026: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Oct 7, 2024 · Class I · Z-0291-2025: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- Oct 7, 2024 · Class I · Z-0293-2025: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- Oct 7, 2024 · Class I · Z-0290-2025: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- Mar 19, 2024 · Class I · Z-1501-2024: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- Mar 19, 2024 · Class I · Z-1503-2024: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- Mar 19, 2024 · Class I · Z-1502-2024: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- Mar 19, 2024 · Class I · Z-1499-2024: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- Mar 19, 2024 · Class I · Z-1500-2024: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- Nov 27, 2023 · Class II · Z-0638-2024: The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for pat
- May 25, 2023 · Class II · Z-2106-2023: There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
- May 1, 2023 · Class I · Z-1650-2023: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue ca
- May 1, 2023 · Class I · Z-1649-2023: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue ca
- May 1, 2023 · Class I · Z-1651-2023: Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue ca
- Mar 1, 2023 · Class I · Z-1288-2023: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may 
- Mar 1, 2023 · Class I · Z-1287-2023: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may 
- Dec 22, 2021 · Class I · Z-0494-2022: Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a
- Jul 26, 2021 · Class II · Z-2287-2021: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is descri
- Jul 26, 2021 · Class II · Z-2289-2021: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is descri
- Jul 26, 2021 · Class II · Z-2288-2021: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is descri
- Nov 19, 2019 · Class I · Z-0945-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0948-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0949-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0950-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0951-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0944-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0946-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0947-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0952-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0954-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0942-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0943-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de
- Nov 19, 2019 · Class I · Z-0953-2020: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This de

## Indications for use
The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.

Source page: https://510kreport.com/device/K181166
Methodology: https://510kreport.com/methodology