510(k) · Cleared
Recalled · Class I · 2026Trilogy Evo Universal
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 Jul 18, 2019 as substantially equivalent to K111610 (Respironics, Inc., 2011) and 2 other predicates after a 442-day review. Its family tree reaches back 12 generations to 1991. 10 of the 94 devices in its family, counting itself, have a Class I recall. It has been recalled 13 times, including 12 Class I recalls.
- Decided
- Jul 18, 2019
- Review
- 442 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 13 (12 Class I)
- Predicates
- 3
Its longest line of descent runs back 12 generations to K902859 (1991). 93 ancestors in all, the oldest K841279 (1984). No later device cites it as a predicate yet. 10 of the 94 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations between
- 3 generations backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- 2 generations backK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- 1 generation backK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- This deviceK181170 Trilogy Evo UniversalRespironics, Inc. · 2019
Show all 12 generations
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 10 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 9 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 8 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 7 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 6 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 5 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- 2 generations backK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- 1 generation backK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- This deviceK181170 Trilogy Evo UniversalRespironics, Inc. · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −11 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −10 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −9 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −8 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −7 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −6 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| −2 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| −1 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| 0 (this device) | K181170 | Trilogy Evo Universal | Respironics, Inc. | 2019 | — |
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 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 10 | 2 |
| 1999 | 6 | 0 |
| 2000 | 6 | 1 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 1 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 1 |
| 2010 | 3 | 2 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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.
10 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? (3)
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 |
|---|---|---|---|
| * | K111610 | Trilogy Series Ventilator with OximetrySummary page 4…DQA, Oximeter CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Primary Predicate Device: Trilogy Series of Ventilators with Oximetry (K111610) Predicate Devices: Breas Medical, Vivo 60 (K160481) Puritan Bennett 840 (K151252) Referen… | 2011 |
| * | K160481 | Vivo 60Summary page 4…as, Carbon-Dioxide, Gaseous-Phase Primary Predicate Device: Trilogy Series of Ventilators with Oximetry (K111610) Predicate Devices: Breas Medical, Vivo 60 (K160481) Puritan Bennett 840 (K151252) Reference Device: Philips NM3 Monitor, Model 7900 (K091459)… | 2016 |
| * | K151252 | Puritan Bennett 840 Series Ventilator SystemSummary page 4…e: Trilogy Series of Ventilators with Oximetry (K111610) Predicate Devices: Breas Medical, Vivo 60 (K160481) Puritan Bennett 840 (K151252) Reference Device: Philips NM3 Monitor, Model 7900 (K091459) Respironics Inc.… | 2016 |
| † | K091459 | Philips NM3 Monitor, Model 7900 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 2, 2026 | Class I | Z-1649-2026 | Software design | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. |
| Mar 2, 2026 | Class I | Z-1617-2026 | Under Investigation by firm | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. |
| Oct 7, 2024 | Class I | Z-0292-2025 | Device Design | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. |
| Jul 16, 2024 | Class I | Z-2944-2024 | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. |
| Jul 16, 2024 | Class I | Z-2942-2024 | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. |
| Jul 16, 2024 | Class I | Z-2943-2024 | Device Design | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. |
| Mar 19, 2024 | Class I | Z-1505-2024 | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Mar 19, 2024 | Class I | Z-1504-2024 | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| May 1, 2023 | Class I | Z-1652-2023 | Under Investigation by firm | The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients… |
| Mar 1, 2023 | Class I | Z-1289-2023 | Under Investigation by firm | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the… |
| Dec 22, 2021 | Class I | Z-0493-2022 | Mixed-up of materials/components | Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the… |
| Dec 22, 2021 | Class I | Z-0494-2022 | Mixed-up of materials/components | Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the… |
| Jul 26, 2021 | Class II | Z-2290-2021 | Labeling design | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous… |
The 5 latest of 13 recalls; the web page lists all.
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.
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K093905Trilogy 202 VentilatorRespironics, Inc. · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 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
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- 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
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 32 of the 93 ancestors have a recall of any class; 9 have a Class I recall.
- 4 other devices also cite its predicate K111610.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It may be used for both invasive and non-invasive ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181170: Trilogy Evo Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181170
Report an extraction error
Are you the manufacturer?
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