510(k) · Cleared
ClearedPuritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan-Bennett · CBK Ventilator, Continuous, Facility Use
Cleared on Aug 13, 2002 as substantially equivalent to K902859 (Siemens Life Support Systems, 1991) and 3 other predicates after a 91-day review. Its family tree reaches back 3 generations to 1991. 19 of the 59 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it.
- Decided
- Aug 13, 2002
- Review
- 91 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K902859 (1991). 6 ancestors in all. 52 later devices descend from it, 2 citing it directly. 19 of the 59 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK961687 EVITA 4Drager, Inc. · 1996
- 1 generation backK970165 Evita 2 DuraDrager, Inc. · 1997
- This deviceK021573 Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus…Puritan-Bennett · 2002
- Descendant · cites it directly · 51 of its ownK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- Descendant · 2 generations on · 36 of its ownK061090 Galileo Gold AsvHamilton Medical AG · 2006
- Descendant · 3 generations on · 26 of its ownK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- Descendant · 2 generations on · 23 of its ownK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
- Descendant · 3 generations on · 21 of its ownK080181 Modification to Galileo GoldHamilton Medical AG · 2008
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 52 · See all- K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · cites it directly51descendants
- K061090Galileo Gold AsvHamilton Medical AG · 2006 · 2 generations on36descendants
- K070513Hamilton-G5Hamilton Medical AG · 2007 · 3 generations on26descendants
- K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa · 2008 · 2 generations on23descendants
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −1 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| 0 (this device) | K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option | Puritan-Bennett | 2002 | — |
| +1 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| +2 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| +3 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| +2 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor… | Drager Medical AG & Co. Kgaa | 2008 | — |
| +3 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 1 |
| 2007 | 3 | 0 |
| 2008 | 3 | 1 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 5 | 3 |
| 2012 | 6 | 2 |
| 2013 | 2 | 2 |
| 2014 | 1 | 1 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 3 | 2 |
| 2019 | 3 | 1 |
| 2020 | 3 | 2 |
| 2021 | 2 | 1 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
19 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? (4)
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 |
|---|---|---|---|
| * | K902859 | Servo Ventilator 300Summary page 1…Siemens Servo 300 with Pressure Regulated Volume Control (PRVC) and Volume support (VS), K902859 Draeger Evita 4 with AutoFlow, K96 1687 Draeger Evita… | 1991 |
| * | K961687 | EVITA 4Summary page 1…Volume Control (PRVC) and Volume support (VS), K902859 Draeger Evita 4 with AutoFlow, K96 1687 Draeger Evita 2 Dura with AutoFlow, K970 165 Hamilton… | 1996 |
| * | K970165 | Evita 2 DuraSummary page 1…K902859 Draeger Evita 4 with AutoFlow, K96 1687 Draeger Evita 2 Dura with AutoFlow, K970 165 Hamilton Galileo with Adaptive Pressure Ventilation (… | 1997 |
| * | K001686 | Galileo Ventilator | 2000 |
What descends from it? (52)
See all 522 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (19 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.
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
Nearest 12 of 19 shown.
Nearest 5 of 19; all are on the web page.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K051263 (Drager Medical AG & Co. Kgaa, 2005) has gone furthest, with 51 descendants of its own.
- 9 other devices also cite its predicate K902859.
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 840 Ventilator with Volume Ventilation PlusT"Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The 840 Ventilator with Neomode and Volume Ventilation Plu? Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients…
Read the full statement (123 words)
The 840 Ventilator with Volume Ventilation PlusT"Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
The 840 Ventilator with Neomode and Volume Ventilation Plu? Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients with Ideal Body Weights (IBW) as low as 0.5kg, is intended to cover a variety of clinical conditions. The 840 Ventilatory with Neomode and Volume Ventilation Plus Options 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/K021573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021573: Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021573
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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