510(k) · Cleared
Recalled · Class I · 2021Trilogy Series Ventilator with Oximetry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 14, 2011 as substantially equivalent to K061627 (Versamed Medical Systems, Inc., 2006) and 3 other predicates after a 127-day review. Its family tree reaches back 9 generations to 1991. 13 of the 82 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Oct 14, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2 (2 Class I)
- Predicates
- 4
Its longest line of descent runs back 9 generations to K902859 (1991). 70 ancestors in all, the oldest K841279 (1984). 11 later devices descend from it, 5 citing it directly. 13 of the 82 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- Descendant · 2 generations on · 7 of its ownK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- Descendant · cites it directly · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 7 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 6 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 5 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 4 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013 · cites it directly8descendants
- K160481Vivo 60Breas Medical AB · 2016 · 2 generations on7descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · cites it directly6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · cites it directly5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −7 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −6 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −5 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −4 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −2 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | — |
| +1 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| +2 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| +1 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +1 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +2 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 9 | 2 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 2 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2019 | 2 | 2 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
13 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061627 | Modification to I Vent 201Summary page 2…dards). Predicate Device Name(s) and 1. Versamed iNent 201 Portable Ventilator with 5 10O(k) numbers: Pulse Oximeter (cleared under K061627 - date of concurrence: June 29, 2006) 2. Res… | 2006 |
| * | K093905 | Trilogy 202 VentilatorSummary page 2…ntilatory Support Systems previously cleared under: - Trilogy 202 Ventilator - K093905 - date of concurrence: May 12, 2010.… | 2010 |
| * | K093416 | Trilogy 200 VentilatorSummary page 2…093905 - date of concurrence: May 12, 2010. - Trilogy 200 Ventilator - K0934 16 -date of concurrence: January 29, 2010.… | 2010 |
| * | K083526 | Trilogy 100 VentilatorSummary page 2…16 -date of concurrence: January 29, 2010. - Trilogy 100 Ventilator - K083526 - date of concurrence: March 13, 2009. Reason for submission:… | 2009 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (13 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2021 | Class I | Z-1956-2021 | Device Design | 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 chemicals. |
| Jun 12, 2018 | Class I | Z-0785-2022 | Device Design | 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. This 2018 correction has been… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093905Trilogy 202 VentilatorRespironics, Inc. · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 24 of the 70 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K123144 (Ge Healthcare, Breas Medical AB, 2013) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K061627.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
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…
Read the full statement (143 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111610: Trilogy Series Ventilator with Oximetry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111610
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026