510(k) · Cleared
Recalled · Class I · 2014Nellcor Puritan Bennett, 840 Ventilator System (Model 840)
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 Apr 30, 1998 as substantially equivalent to K902506 (Puritan Bennett Corp., 1991) and 3 other predicates after a 448-day review. Its family tree reaches back 2 generations to 1991. 49 of the 181 devices in its family, counting itself, have a Class I recall. 174 later devices descend from it. It has been recalled 8 times, including a Class I recall.
- Decided
- Apr 30, 1998
- Review
- 448 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 8 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 2 generations to K902859 (1991). 6 ancestors in all, the oldest K902506 (1991). 174 later devices descend from it, 7 citing it directly. 49 of the 181 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 1 generation backK961687 EVITA 4Drager, Inc. · 1996
- This deviceK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998
- Descendant · cites it directly · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 3 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 4 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 174 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 174 · See all- K013642AVEABird Products Corp. · 2002 · cites it directly133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 2 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 3 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 3 generations on87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −1 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| 0 (this device) | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | — |
| +1 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +2 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +3 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
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 |
|---|---|---|
| 1998 | 2 | 1 |
| 2002 | 4 | 2 |
| 2003 | 1 | 0 |
| 2004 | 6 | 1 |
| 2005 | 4 | 0 |
| 2006 | 9 | 1 |
| 2007 | 6 | 1 |
| 2008 | 12 | 2 |
| 2009 | 6 | 1 |
| 2010 | 8 | 2 |
| 2011 | 14 | 7 |
| 2012 | 15 | 5 |
| 2013 | 10 | 4 |
| 2014 | 6 | 1 |
| 2015 | 8 | 1 |
| 2016 | 8 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 8 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 5 | 1 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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.
49 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 |
|---|---|---|---|
| * | K902506 | 7200AE Microprocessor Ventilator W/Enhanced Hard.Summary page 1…medical devices: Predicate Device 510(k) Number Classification Puritan-Bennett Corp. 7200 Series Ventilator Bear Medical Systems Inc. K912619 Bear 1000 Ventilator K902506/B (7200ae) Continuous, Critical Care Ventilator ' Continuous, Critical Care Ventilator Siemens Corp. K902859 Continuous, Criti… | 1991 |
| * | K912619 | Bear 7 VentilatorSummary page 1…ce to the following predicate medical devices: Predicate Device 510(k) Number Classification Puritan-Bennett Corp. 7200 Series Ventilator Bear Medical Systems Inc. K912619 Bear 1000 Ventilator K902506/B (7200ae) Continuous, Critical Care Ventilator ' Continuous, Critical Care Ventilator Siemens… | 1992 |
| * | K902859 | Servo Ventilator 300Summary page 1…Bear Medical Systems Inc. K912619 Bear 1000 Ventilator K902506/B (7200ae) Continuous, Critical Care Ventilator ' Continuous, Critical Care Ventilator Siemens Corp. K902859 Continuous, Critical Servo 300 Ventilator Care Ventilator Dréager K961687 Continuous, Critical Evita 4 Ventilator Care Ventilat… | 1991 |
| * | K961687 | EVITA 4Summary page 1…e) Continuous, Critical Care Ventilator ' Continuous, Critical Care Ventilator Siemens Corp. K902859 Continuous, Critical Servo 300 Ventilator Care Ventilator Dréager K961687 Continuous, Critical Evita 4 Ventilator Care Ventilator 1. DEVICE DESCRIPTION: The device is a critical care v… | 1996 |
What descends from it? (174)
See all 1747 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013642 | AVEA Class I | 2002 | 133 |
| K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option Class I | 1998 | 55 |
| K062093 | Avea Ventilator | 2006 | 21 |
| K984379 | Nellcor Puritan Bennett, 760 Ventilator System | 1998 | 8 |
| K023350 | Esprit Ventilator with Respiratory Mechanics Class I | 2002 | 2 |
| K072926 | Helontix Vent | 2008 | 0 |
| K063650 | Ventilator with Respiratory Mechanics, Model 840 | 2007 | 0 |
Has anything in its family been recalled? (49 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2014 | Class II | Z-1809-2014 | Component design/selection | In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus… |
| Jun 3, 2014 | Class II | Z-1844-2014 | Nonconforming Material/Component | Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath… |
| 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… |
| Jan 25, 2013 | Class II | Z-0822-2014 | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators… |
| Jan 25, 2013 | Class II | Z-0821-2014 | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators… |
| Mar 21, 2008 | Not classified | Z-1692-2008 | Process control | Wiring in battery back-up power supply may short and cause thermal damage to ventilator. |
| Mar 12, 2007 | Not classified | Z-0760-2007 | Other | In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a… |
| Apr 20, 2005 | Not classified | Z-1085-05 | Other | Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection. |
The 5 latest of 8 recalls; the web page lists all.
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 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 2 generations on · ◆ in the 2004 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
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 4 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 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
Nearest 12 of 48 shown.
Nearest 5 of 48; 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 5.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K013642 (Bird Products Corp., 2002) has gone furthest, with 133 descendants of its own.
- 6 other devices also cite its predicate K902506.
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 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/K970460 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970460
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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