510(k) · Cleared
Recalled · Class I · 2026VOCSN Unified Respiratory System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventec Life Systems, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 7, 2017 as substantially equivalent to K111610 (Respironics, Inc., 2011) and 4 other predicates after a 175-day review. Its family tree reaches back 10 generations to 1991. 12 of the 95 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 16 times, including 14 Class I recalls.
- Decided
- Apr 7, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 16 (14 Class I)
- Predicates
- 5
Its longest line of descent runs back 10 generations to K902859 (1991). 88 ancestors in all, the oldest K841279 (1984). 6 later devices descend from it, 1 citing it directly. 12 of the 95 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations between
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017
- 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)
- Descendant · 2 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK233452 Vivo 45 LSBreas Medical AB · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK241135 RESPOND (R) VentilatorCorvent Medical, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 8 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 7 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 6 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 5 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 4 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K181166Trilogy EvoRespironics, Inc. · 2019 · cites it directly5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 2 generations on2descendants
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 2 generations on0descendants
- K233452Vivo 45 LSBreas Medical AB · 2025 · 3 generations on0descendants
- K241135RESPOND (R) VentilatorCorvent Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −9 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −8 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −7 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −6 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −5 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −3 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| 0 (this device) | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | — |
| +1 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +2 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +2 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
| +3 | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | 1 |
| +2 | K241135 | RESPOND (R) Ventilator | Corvent Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 2 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 2 | 2 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 1 |
| 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.
12 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 5…nal Premarket Notification Primary Predicate Device Mechanical ventilator component Information: Respironics Trilogy Series Ventilator (K111610) Reference Predicate Device Mechanical ventilator component Information: CareFusion Palmtop Ventil… | 2011 |
| * | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10Summary page 5…es Ventilator (K111610) Reference Predicate Device Mechanical ventilator component Information: CareFusion Palmtop Ventilator PTV-8 & -10 (K070594) CareFusion LTV 1200 Ventilator (K060647) Oxygen concentra… | 2007 |
| * | K120785 | Omni 3 Oxygen SystemSummary page 5…usion LTV 1200 Ventilator (K060647) Oxygen concentrator component Omni 3 (eQuinox) Oxygen System (K120785) Cough Assist component Respironics Cough Assist T70 (K12… | 2012 |
| * | K121955 | Coughassist T70 DeviceSummary page 5…Omni 3 (eQuinox) Oxygen System (K120785) Cough Assist component Respironics Cough Assist T70 (K121955) Suction Pump component Precision Medical Easy Go Vac PM… | 2012 |
| * | K140179 | Easy GO VacSummary page 5…espironics Cough Assist T70 (K121955) Suction Pump component Precision Medical Easy Go Vac PM66 (K140179) Heated Patient Circuits Respironics (Philips) Disposable… | 2014 |
| † | K060647 | LTV 1200 Ventilator | 2006 |
| † | K110398 | Respironics Disposable Heated Wire Circuits | 2011 |
| † | K973797 | Breathing Circuit Bacterial Filter | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181166 | Trilogy Evo Class I | 2019 | 5 |
Has anything in its family been recalled? (12 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2026 | Class I | Z-0129-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0130-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0127-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0124-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0131-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0123-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0128-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0125-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0126-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0122-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| Sep 17, 2026 | Class I | Z-0132-2027 | Under Investigation by firm | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. |
| May 8, 2026 | Class II | Z-2525-2026 | Vendor change control | Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and… |
| Mar 25, 2026 | Class I | Z-1942-2026 | Process change control | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to… |
| Feb 3, 2025 | Class I | Z-1196-2025 | Component change control | Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less… |
| Jan 9, 2024 | Class I | Z-1070-2024 | Process control | The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the… |
| May 10, 2021 | Class II | Z-1902-2021 | Device Design | Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy. |
The 5 latest of 16 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
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of 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
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 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
- K181166Trilogy EvoRespironics, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 131 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 11; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 31 of the 88 ancestors have a recall of any class; 9 have a Class I recall.
- Of its descendants, K181166 (Respironics, Inc., 2019) has gone furthest, with 5 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. 2017, 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 VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator…
Read the full statement (106 words)
The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.
The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162877: VOCSN Unified Respiratory System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162877
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