# K111610: Trilogy Series Ventilator with Oximetry

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Oct 14, 2011 after 127 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902859 (1991). 70 ancestors in all.
11 later devices descend from it; 5 cite it directly.
13 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061627: Modification to I Vent 201, Versamed Medical Systems, Inc. (2006) Summary page 2.
- K093905: Trilogy 202 Ventilator, Respironics, Inc. (2010) Summary page 2.
- K093416: Trilogy 200 Ventilator, Respironics, Inc. (2010) Summary page 2.
- K083526: Trilogy 100 Ventilator, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 2.

## Most influential descendants
- K123144: VIVO 50 (2013), 8 descendants of its own
- K160481: Vivo 60 (2016), 7 descendants of its own
- K162877: VOCSN Unified Respiratory System (2017), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own

## Recalls of this device
- Jun 14, 2021 · Class I · Z-1956-2021: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemic
- Jun 12, 2018 · Class I · Z-0785-2022: In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles

## Indications for use
The Trilogy Series of Ventilators (with or without the oximetry interface kit) arc intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy is intended for pediatric through adult patients weighing at least 5 kg (1 lbs). The Oximetry Interface kit is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO 2 ) and pulse rate. The device is intended to be used in the home, hospitals and institutions, and portable applications such as wheelchairs and gurneys. It may be used for both invasive and noninvasive ventilation. It is not intended to be used as a transport ventilator. Compatibility The Trilogy Oximetry Interface kit is compatible with the following Philips Respironies Trilogy ventilators: --Trilogy 100 --Trilogy200. *-TrilogyO2 --Trilogy202 The kit is compatible with the Masimo LNCS Series Sensor Accessories

Source page: https://510kreport.com/device/K111610
Methodology: https://510kreport.com/methodology