# K093416: Trilogy 200 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 29, 2010 after 88 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902859 (1991). 32 ancestors in all.
19 later devices descend from it; 6 cite it directly.
13 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083526: Trilogy 100 Ventilator, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 1.

## Most influential descendants
- K111610: Trilogy Series Ventilator with Oximetry (2011), 11 descendants of its own
- K133868: Astral Ventilator (2014), 10 descendants of its own
- 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

## Recalls of this device
- Dec 7, 2022 · Class I · Z-0883-2023: The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam co
- 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
- Jan 18, 2016 · Class II · Z-1065-2016: Software Issue
- Feb 11, 2014 · Class I · Z-1143-2014: Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.
- Apr 27, 2012 · Class I · Z-2024-2012: The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.

## Indications for use
The Respironics Trilogy 200 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.

Source page: https://510kreport.com/device/K093416
Methodology: https://510kreport.com/methodology