510(k) · Cleared
Recalled · Class I · 2022Trilogy 200 Ventilator
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 Jan 29, 2010 as substantially equivalent to K083526 (Respironics Inc., Sleep & Home Respiratory Group, 2009) after an 88-day review. Its family tree reaches back 6 generations to 1991. 13 of the 52 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it. It has been recalled 5 times, including 4 Class I recalls.
- Decided
- Jan 29, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 5 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K902859 (1991). 32 ancestors in all, the oldest K841279 (1984). 19 later devices descend from it, 6 citing it directly. 13 of the 52 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK961687 EVITA 4Drager, Inc. · 1996
- 4 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 3 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 2 generations backK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- 1 generation backK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- This deviceK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 10 of its ownK133868 Astral VentilatorResmed, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 19 · See all- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · cites it directly11descendants
- K133868Astral VentilatorResmed, Ltd. · 2014 · cites it directly10descendants
- K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013 · 2 generations on8descendants
- K160481Vivo 60Breas Medical AB · 2016 · 2 generations on7descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −4 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −3 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −2 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| −1 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| 0 (this device) | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | — |
| +1 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| +1 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 2 |
| +2 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| +2 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| +2 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 1 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2012 | 3 | 1 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
| 2016 | 3 | 1 |
| 2017 | 1 | 1 |
| 2018 | 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? (1)
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 |
|---|---|---|---|
| * | K083526 | Trilogy 100 VentilatorSummary page 1…tion Reference 21 CFR 868.5895 Product Code CBK - Continuous Ventilator, Facility Use Predicate Device(s) Respironics Trilogy 100 (K083526) Labeling Draft Labeling can be found in Tab 5. Indications for Use The Respironics Trilogy2… | 2009 |
What descends from it? (19)
See all 196 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111610 | Trilogy Series Ventilator with Oximetry Class I | 2011 | 11 |
| K133868 | Astral Ventilator | 2014 | 10 |
| K121623 | Bipap a 40 Ventilatory Support System Class I | 2012 | 6 |
| K151120 | Simple T Pediatric Nasal Mask | 2016 | 0 |
| K120562 | Performax Pediatric EE Total Face Mask | 2012 | 0 |
| K120639 | Performax Pediatric SE Total Face Mask | 2012 | 0 |
Has anything in its family been recalled? (13 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2022 | Class I | Z-0883-2023 | Process design | 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 could potentially block air inlet, which… |
| 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. |
| Jan 18, 2016 | Class II | Z-1065-2016 | Software design | Software Issue |
| Feb 11, 2014 | Class I | Z-1143-2014 | Component design/selection | 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 | Component design/selection | The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. |
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.
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Direct predicate · ◆ on the line of descent in 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
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K152068Astral 100/150Resmed, Ltd. · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K172875Astral 100/150Resmed, Ltd. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 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 19 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 15 of the 32 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K111610 (Respironics, Inc., 2011) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K083526.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Respironics Trilogy 200 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy200 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093416 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093416: Trilogy 200 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093416
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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