# K093905: Trilogy 202 Ventilator

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: May 12, 2010 after 141 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
7 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111610: Trilogy Series Ventilator with Oximetry (2011), 11 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
- K181166: Trilogy Evo (2019), 5 descendants of its own

## Recalls of this device
- 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 202 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

Source page: https://510kreport.com/device/K093905
Methodology: https://510kreport.com/methodology