510(k) · Cleared
ClearedPB 840 Ventilator System with Leak Compensation Option, Model 840
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 Apr 2, 2009 as substantially equivalent to K001646 (Puritan Bennett Corp., 2000) and 2 other predicates after a 111-day review. Its family tree reaches back 11 generations to 1991. 11 of the 79 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Apr 2, 2009
- Review
- 111 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K902859 (1991). 72 ancestors in all, the oldest K883038 (1988). 6 later devices descend from it, 1 citing it directly. 11 of the 79 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations between
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- This deviceK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK103211 Avea VentilatorCare Fusion · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK131252 Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK162738 Puritan Bennett 980 Ventilator SystemCovidien · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK162832 731 Series VentilatorsZOLL Medical Corporation · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK233486 731 Series VentilatorZOLL Medical Corporation · 2024
Show all 11 generations
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 4 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- This deviceK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
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- K103211Avea VentilatorCare Fusion · 2011 · cites it directly5descendants
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 2 generations on2descendants
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 3 generations on1descendant
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 2 generations on1descendant
- K233486731 Series VentilatorZOLL Medical Corporation · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −10 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −9 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −8 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −7 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −6 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −5 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −1 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| 0 (this device) | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | — |
| +1 | K103211 | Avea Ventilator | Care Fusion | 2011 | Class I |
| +2 | K131252 | Puritan Bennett 980 Series Ventilator System | Covidien | 2014 | Class I |
| +3 | K162738 | Puritan Bennett 980 Ventilator System | Covidien | 2017 | Class I |
| +2 | K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017 | Class I |
| +3 | K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 9 | 3 |
| 1999 | 5 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2014 | 1 | 1 |
| 2017 | 2 | 2 |
| 2020 | 1 | 1 |
| 2024 | 1 | 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.
11 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? (3)
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 OptionSummary page 1…Ventilation, K984535 * Puritan-Bennett Corp. 840 Ventilator System with Neomode Legally Marketed Option, K001646 * Puritan-Bennett Corp. 840 Ventilator System with Volume (Unmodified) Device:… | 2000 |
| * | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Summary page 1…* Puritan-Bennett Corp. 840 Ventilator System with NeoMode, Predicate Devices: K001646 * Maquet Servo I, K073179 * Hamilton Medical, G5 Ventilator, K070513 Device Description: The Leak Compensation Opt… | 2008 |
| * | K070513 | Hamilton-G5Summary page 1…ces: K001646 * Maquet Servo I, K073179 * Hamilton Medical, G5 Ventilator, K070513 Device Description: The Leak Compensation Option enables the. 840 Ventilator System to automatically detect and characterize g… | 2007 |
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 |
|---|---|---|---|
| K103211 | Avea Ventilator Class I | 2011 | 5 |
Has anything in its family been recalled? (11 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
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 4 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
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 117 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 21 of the 72 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K103211 (Care Fusion, 2011) has gone furthest, with 5 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. 2009, 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 Leak Compensation Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions. The 840 Ventilator System with Leak Compensation Options is intended for a wide range of patients ranging from neonate to adult (VT 5-2500 mL…
Read the full statement (120 words)
The 840 Ventilator System with Leak Compensation Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions.
The 840 Ventilator System with Leak Compensation Options is intended for a wide range of patients ranging from neonate to adult (VT 5-2500 mL with NecMode) or from infant to adult (VT 25-2500 mL).
The 840 Ventilator System with Leak Compensation is intended for use in hospital 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/K083693 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083693: PB 840 Ventilator System with Leak Compensation Option, Model 840.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083693
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