510(k) · Cleared
Recalled · 2009Carina Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical B.V. · CBK Ventilator, Continuous, Facility Use
Cleared on Jun 14, 2006 as substantially equivalent to K052554 (Versamed Medical Systems, Inc., 2005) and 4 other predicates after a 90-day review. Its family tree reaches back 7 generations to 1991. 9 of the 77 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled once.
- Decided
- Jun 14, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K902859 (1991). 54 ancestors in all, the oldest K883038 (1988). 22 later devices descend from it, 2 citing it directly. 9 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 5 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 4 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 3 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 2 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 1 generation backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- This deviceK060705 Carina HomeDraeger Medical B.V. · 2006
- Descendant · cites it directly · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK113288 Vpap ST-aResmed, Ltd. · 2012
- Descendant · 3 generations on · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 4 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K103167Stellar 150Resmed Germany, Inc. · 2011 · cites it directly20descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on8descendants
- K113288Vpap ST-aResmed, Ltd. · 2012 · 2 generations on7descendants
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −5 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −3 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −2 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −1 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K060705 | Carina Home | Draeger Medical B.V. | 2006 | — |
| +1 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +2 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +2 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| +3 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +4 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 2 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2011 | 2 | 0 |
| 2012 | 5 | 2 |
| 2013 | 2 | 1 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
9 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 |
|---|---|---|---|
| * | K052554 | Modification to: Ivent 201 Portable VentilatorSummary page 2…ADrfger and Siemens Company Predicate Devices: 510(k) Number Device Name K052554 Vent 201 Portable Ventilator K040790 LTV 1000 Ventilator K033008 Air Safety HEPA and… | 2005 |
| * | K040790 | Modification to LTV 1000 Ventilator/Breathing CircuitsSummary page 2…ADrfger and Siemens Company Predicate Devices: 510(k) Number Device Name K052554 Vent 201 Portable Ventilator K040790 LTV 1000 Ventilator K033008 Air Safety HEPA and non-HEPA Filters K003068 Savina… | 2004 |
| * | K033008 | Air Safety Hepa and Non-Hepa FiltersSummary page 2…any Predicate Devices: 510(k) Number Device Name K052554 Vent 201 Portable Ventilator K040790 LTV 1000 Ventilator K033008 Air Safety HEPA and non-HEPA Filters K003068 Savina K970839 Siemens Servo Ventilator… | 2004 |
| * | K003068 | SavinaSummary page 2…e K052554 Vent 201 Portable Ventilator K040790 LTV 1000 Ventilator K033008 Air Safety HEPA and non-HEPA Filters K003068 Savina K970839 Siemens Servo Ventilator 300A Substantial Equivalence: The Carina home is similar to… | 2001 |
| * | K970839 | Servo Ventilator 300ASummary page 2…201 Portable Ventilator K040790 LTV 1000 Ventilator K033008 Air Safety HEPA and non-HEPA Filters K003068 Savina K970839 Siemens Servo Ventilator 300A Substantial Equivalence: The Carina home is similar to the homecare features to he Ven… | 1997 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2009 | Not classified | Z-1263-2009 | Software design | The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery. |
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.
- 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
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants 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 15 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 54 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K103167 (Resmed Germany, Inc., 2011) has gone furthest, with 20 descendants of its own.
- 4 other devices also cite its predicate K052554.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen). Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060705: Carina Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060705
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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