# K083526: Trilogy 100 Ventilator

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Mar 13, 2009 after 105 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 8 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902859 (1991). 31 ancestors in all.
26 later devices descend from it; 6 cite it directly.
13 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070328: Bipap Synchrony with Avaps, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K022750: PLV Continuum Ventilator, Model P1000, Respironics California, Inc. (2003) Summary page 1.
- K984056: LTV 1000, Pulmonetic Systems, Inc. (1999) Summary page 1.
- K051767: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (2005) Summary page 1.
- K992133: Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil, Newport Medical Instruments, Inc. (2000) Summary page 5.

## Most influential descendants
- K093416: Trilogy 200 Ventilator (2010), 19 descendants of its own
- K111610: Trilogy Series Ventilator with Oximetry (2011), 11 descendants of its own
- K133868: Astral Ventilator (2014), 10 descendants of its own
- K112754: IVENT101 (2012), 9 descendants of its own
- K123144: VIVO 50 (2013), 8 descendants of its own

## Recalls of this device
- Dec 7, 2022 · Class I · Z-0884-2023: 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
- Dec 7, 2022 · Class I · Z-0882-2023: 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.
- Oct 11, 2011 · Not classified · Z-0296-2012: Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up th
- Jun 10, 2010 · Not classified · Z-1896-2010: It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.

## Indications for use
The Respironics Trilogy100 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy100 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. It is not intended to be used as a transport ventilator.

Source page: https://510kreport.com/device/K083526
Methodology: https://510kreport.com/methodology