# K181170: Trilogy Evo Universal

- 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: 13 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902859 (1991). 93 ancestors in all.
No later device cites it as a predicate yet.
10 of 94 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.

## Recalls of this device
- Mar 2, 2026 · Class I · Z-1649-2026: 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-1617-2026: 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.
- Oct 7, 2024 · Class I · Z-0292-2025: 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.
- Jul 16, 2024 · Class I · Z-2944-2024: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- Jul 16, 2024 · Class I · Z-2942-2024: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- Jul 16, 2024 · Class I · Z-2943-2024: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- Mar 19, 2024 · Class I · Z-1505-2024: 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-1504-2024: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- May 1, 2023 · Class I · Z-1652-2023: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended
- Mar 1, 2023 · Class I · Z-1289-2023: 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-0493-2022: 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
- 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-2290-2021: 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

## Indications for use
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal 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/hospital settings and non-emergency transport settings for example wheelchair. It may be used for both invasive and non-invasive ventilation.

Source page: https://510kreport.com/device/K181170
Methodology: https://510kreport.com/methodology