510(k) · Cleared
Cleared840 Ventilator System with Expanded Neomode Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Nellcor Puritan Bennett, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Mar 11, 2010 as substantially equivalent to K001646 (Puritan Bennett Corp., 2000) and 1 other predicate after a 176-day review. Its family tree reaches back 6 generations to 1991. 9 of the 36 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Mar 11, 2010
- Review
- 176 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K902859 (1991). 24 ancestors in all, the oldest K895541 (1990). 11 later devices descend from it, 2 citing it directly. 9 of the 36 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 backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 4 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 3 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 2 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 1 generation backK081837 Avea VentilatorCardinal Health 207, Inc. · 2008
- This deviceK092847 840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK151252 Puritan Bennett 840 Series Ventilator SystemCovidien LP · 2016
- Descendant · 2 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK131252 Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK162738 Puritan Bennett 980 Ventilator SystemCovidien · 2017 · Recalled (Class I)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP · 2016 · cites it directly7descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on2descendants
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · cites it directly2descendants
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 2 generations on1descendant
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 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −4 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −3 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −1 | K081837 | Avea Ventilator | Cardinal Health 207, Inc. | 2008 | — |
| 0 (this device) | K092847 | 840 Ventilator System with Expanded Neomode Option | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2010 | — |
| +1 | K151252 | Puritan Bennett 840 Series Ventilator System | Covidien LP | 2016 | — |
| +2 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +3 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K131252 | Puritan Bennett 980 Series Ventilator System | Covidien | 2014 | Class I |
| +2 | K162738 | Puritan Bennett 980 Ventilator System | Covidien | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 1 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2019 | 2 | 2 |
| 2020 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K001646 | Puritan-Bennett 840 Ventilator System with Neomode Option | 2000 |
| * | K081837 | Avea VentilatorSummary page 2…tor System with Expanded NeoMode Option, has the same intended use, general design and fundamental scientific technology as the predicate devices (KOO 1646 and K08 1837). The 840 Ventilator System with Expanded NeoMode Option uses technology substantially equivalent to the CBK Family of… | 2008 |
What descends from it? (11)
See all 112 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)
No FDA recall names this device.
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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- 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
- K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 117 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 9; 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 2.7 years on median.
- 8 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K151252 (Covidien LP, 2016) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K001646.
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 840 Ventilator System with Expanded NeoMode Option provides continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option, is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg and for use in a wide variety of clinical conditions.
The 840 Ventilator System with Expanded NeoMode Option is intended for use in hospitals and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092847: 840 Ventilator System with Expanded Neomode Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092847
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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