510(k) · Cleared
Recalled · Class I · 2026Trilogy Evo
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 4 other predicates after a 442-day review. Its family tree reaches back 12 generations to 1996. 18 of the 179 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 36 times, including 31 Class I recalls.
- Decided
- Jul 18, 2019
- Review
- 442 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 36 (31 Class I)
- Predicates
- 5
Its longest line of descent runs back 12 generations to K953930 (1996). 173 ancestors in all, the oldest K811102 (1981). 5 later devices descend from it, 4 citing it directly. 18 of the 179 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 8 generations between
- 3 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 2 generations backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 1 generation backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- This deviceK181166 Trilogy EvoRespironics, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233452 Vivo 45 LSBreas Medical AB · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK241135 RESPOND (R) VentilatorCorvent Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK240807 VM-2000Ventis Medical, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 11 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 10 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 9 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 8 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 7 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 6 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 5 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 4 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 3 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 2 generations backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 1 generation backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- This deviceK181166 Trilogy EvoRespironics, Inc. · 2019
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K193586Vivo 45 LSBreas Medical AB · 2021 · cites it directly2descendants
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · cites it directly0descendants
- K233452Vivo 45 LSBreas Medical AB · 2025 · 2 generations on0descendants
- K241135RESPOND (R) VentilatorCorvent Medical, Inc. · 2024 · cites it directly0descendants
- K240807VM-2000Ventis Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −11 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −10 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −9 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −8 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −7 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −6 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −5 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −4 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −3 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| −2 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| −1 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| 0 (this device) | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | — |
| +1 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
| +2 | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | 1 |
| +1 | K241135 | RESPOND (R) Ventilator | Corvent Medical, Inc. | 2024 | — |
| +1 | K240807 | VM-2000 | Ventis Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 10 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 17 | 2 |
| 1999 | 8 | 0 |
| 2000 | 8 | 1 |
| 2001 | 11 | 0 |
| 2002 | 10 | 1 |
| 2003 | 9 | 1 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 1 |
| 2008 | 4 | 0 |
| 2009 | 5 | 2 |
| 2010 | 3 | 2 |
| 2011 | 3 | 1 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
18 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? (5)
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)… | 2011 |
| * | K160481 | Vivo 60Summary page 4…s, 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) VOCSN Unified Respiratory System (URS) (K1… | 2016 |
| * | K151252 | Puritan Bennett 840 Series Ventilator SystemSummary page 4…: Trilogy Series of Ventilators with Oximetry (K111610) Predicate Devices: Breas Medical, Vivo 60 (K160481) Puritan Bennett 840 (K151252) VOCSN Unified Respiratory System (URS) (K162877) BiPAP A40 Ventilatory S… | 2016 |
| * | K162877 | VOCSN Unified Respiratory SystemSummary page 4…: Breas Medical, Vivo 60 (K160481) Puritan Bennett 840 (K151252) VOCSN Unified Respiratory System (URS) (K162877) BiPAP A40 Ventilatory Support System (K121623) Reference Device: Philips NM3 Monitor, Mod… | 2017 |
| * | K121623 | Bipap a 40 Ventilatory Support SystemSummary page 4…itan Bennett 840 (K151252) VOCSN Unified Respiratory System (URS) (K162877) BiPAP A40 Ventilatory Support System (K121623) Reference Device: Philips NM3 Monitor, Model 7900 (K091459) Respironics Inc.… | 2012 |
| † | K091459 | Philips NM3 Monitor, Model 7900 | 2009 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (18 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 2, 2026 | Class I | Z-1647-2026 | 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-1614-2026 | 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. |
| Mar 2, 2026 | Class I | Z-1648-2026 | 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-1646-2026 | 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. |
| Oct 7, 2024 | Class I | Z-0291-2025 | 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. |
| Oct 7, 2024 | Class I | Z-0293-2025 | 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. |
| Oct 7, 2024 | Class I | Z-0290-2025 | 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. |
| Mar 19, 2024 | Class I | Z-1501-2024 | 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-1503-2024 | 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-1502-2024 | 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-1499-2024 | 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-1500-2024 | Device Design | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. |
| Nov 27, 2023 | Class II | Z-0638-2024 | Device Design | The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms… |
| May 25, 2023 | Class II | Z-2106-2023 | Under Investigation by firm | There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive". |
| May 1, 2023 | Class I | Z-1650-2023 | Under Investigation by firm | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to… |
| May 1, 2023 | Class I | Z-1649-2023 | Under Investigation by firm | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to… |
| May 1, 2023 | Class I | Z-1651-2023 | Under Investigation by firm | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to… |
| Mar 1, 2023 | Class I | Z-1288-2023 | 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… |
| Mar 1, 2023 | Class I | Z-1287-2023 | 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-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-2287-2021 | 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… |
| Jul 26, 2021 | Class II | Z-2289-2021 | 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… |
| Jul 26, 2021 | Class II | Z-2288-2021 | 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… |
| Nov 19, 2019 | Class I | Z-0945-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0948-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0949-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0950-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0951-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0944-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0946-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0947-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0952-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0954-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0942-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0943-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
| Nov 19, 2019 | Class I | Z-0953-2020 | Software design | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected… |
The 5 latest of 36 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.
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Direct predicate · ◆ in the 2017 ancestors bar of FIG. 114 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 15 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
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 13 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
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 12 of 17 shown.
Nearest 5 of 17; all are on the web page.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 56 of the 173 ancestors have a recall of any class; 16 have a Class I recall.
- Of its descendants, K193586 (Breas Medical AB, 2021) has gone furthest, with 2 descendants of its own.
- 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
2007high 18 (2008) · low 0 (2022)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
2007high 439 (2014) · low 115 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
2007high 23 (2008) · low 0 (2025)2026
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
2007high 24,928 (2023) · low 1,531 (2007)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 ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo 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, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181166: Trilogy Evo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181166
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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