510(k) · Cleared
Recalled · Class I · 2013Puritan-Bennett 840 Ventilatory System with Bilevel Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 28, 1998 as substantially equivalent to K970460 (Puritan Bennett Corp., 1998) and 3 other predicates after a 7-day review. Its family tree reaches back 3 generations to 1991. 21 of the 63 devices in its family, counting itself, have a Class I recall. 55 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Dec 28, 1998
- Review
- 7 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K902859 (1991). 7 ancestors in all, the oldest K902506 (1991). 55 later devices descend from it, 3 citing it directly. 21 of the 63 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 backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- This deviceK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998
- Descendant · cites it directly · 54 of its ownK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- Descendant · cites it directly · 53 of its ownK040574 Galileo GoldHamilton Medical, Inc. · 2004
- Descendant · 2 generations on · 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
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 55 · See all- K022679RaphaelHamilton Medical AG · 2003 · cites it directly54descendants
- K040574Galileo GoldHamilton Medical, Inc. · 2004 · cites it directly53descendants
- K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · 2 generations on51descendants
- K061090Galileo Gold AsvHamilton Medical AG · 2006 · 2 generations on36descendants
- K070513Hamilton-G5Hamilton Medical AG · 2007 · 3 generations on26descendants
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 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| 0 (this device) | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | — |
| +1 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| +1 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| +2 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 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.
21 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 |
|---|---|---|---|
| * | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Summary page 1…-Bennett Corp. is claiming substantial equivalence to the following three predicate medical devices: Predicate Device 510(k) Number Classification Puritan Bennett Corp. K970460 Class I, 840 Ventilator System Continuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp. K902506B Class II, 7200 Series… | 1998 |
| * | K902506 | 7200AE Microprocessor Ventilator W/Enhanced Hard.Summary page 1…dicate Device 510(k) Number Classification Puritan Bennett Corp. K970460 Class I, 840 Ventilator System Continuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp. K902506B Class II, 7200 Series Ventilator Continuous Ventilator per 21 CFR 868.5895 Drager K961687 Class II, Evita 4 Ventilator Contin… | 1991 |
| * | K961687 | EVITA 4Summary page 1…tor System Continuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp. K902506B Class II, 7200 Series Ventilator Continuous Ventilator per 21 CFR 868.5895 Drager K961687 Class II, Evita 4 Ventilator Continuous Ventilator per 21 CFR 868.5895 Siemens K902859 Class II, Servo 300 Ventilator Continuo… | 1996 |
| * | K902859 | Servo Ventilator 300Summary page 1…ss II, 7200 Series Ventilator Continuous Ventilator per 21 CFR 868.5895 Drager K961687 Class II, Evita 4 Ventilator Continuous Ventilator per 21 CFR 868.5895 Siemens K902859 Class II, Servo 300 Ventilator Continuous Ventilator 840 Ventilator System with BiLevel Option Special 510(k) Submission per… | 1991 |
What descends from it? (55)
See all 553 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (21 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2013 | Class I | Z-0611-2014 | Software design | Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical… |
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.
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- 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
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 12 of 20 shown.
Nearest 5 of 20; all are on the web page.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K022679 (Hamilton Medical AG, 2003) has gone furthest, with 54 descendants of its own.
- 6 other devices also cite its predicate K970460.
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 System with BiLevel Option is used to
provide continuous ventilation to patient’s 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984535: Puritan-Bennett 840 Ventilatory System with Bilevel Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984535
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