510(k) · Cleared
Recalled · Class I · 2013Model 840 Ventilator with Proportional Assist Ventilation Plus Software 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 Apr 4, 2006 as substantially equivalent to K021573 (Puritan-Bennett, 2002) and 1 other predicate after a 120-day review. Its family tree reaches back 7 generations to 1991. 4 of the 34 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Apr 4, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 7 generations to K902859 (1991). 27 ancestors in all, the oldest K902506 (1991). 6 later devices descend from it, 2 citing it directly. 4 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK961687 EVITA 4Drager, Inc. · 1996
- 5 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 4 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 3 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 2 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 1 generation backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- This deviceK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006
- Descendant · cites it directly · 4 of its ownK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK222897 Enlight 2100Timpel S.A. · 2023
- Descendant · 3 generations on · 0 of its ownK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
- Descendant · 3 generations on · 0 of its ownK243765 LuMon (TM) SystemSentec AG · 2025
- Descendant · 2 generations on · 0 of its ownK192584 BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
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- K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011 · cites it directly4descendants
- K222897Enlight 2100Timpel S.A. · 2023 · 2 generations on2descendants
- K250464Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025 · 3 generations on0descendants
- K243765LuMon (TM) SystemSentec AG · 2025 · 3 generations on0descendants
- K192584BEACON Caresystem Model 00002144Mermaid Care A/S · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −5 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −4 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −3 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −2 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −1 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| 0 (this device) | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | Puritan Bennett Corp. | 2006 | — |
| +1 | K103578 | Philips NM3 Respiratory Monitor with Ventassist | Respironics Novametrix, LLC | 2011 | — |
| +2 | K222897 | Enlight 2100 | Timpel S.A. | 2023 | — |
| +3 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025 | — |
| +3 | K243765 | LuMon (TM) System | Sentec AG | 2025 | — |
| +2 | K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | 2019 | — |
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 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 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.
4 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 |
|---|---|---|---|
| * | K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionSummary page 1…21 CFR 868.5895 Substantially Equivalent Devices: Puritan Bennett 840 Ventilator with Volume Ventilation Plus (VV+), K021573. Drager EvitaXL with SmartCare/PS Software Option, K051263 Device D… | 2002 |
| * | K051263 | Evitaxl with Option SmartcareSummary page 1…entilation Plus (VV+), K021573. Drager EvitaXL with SmartCare/PS Software Option, K051263 Device Description: Proportional Assist Ventilation Plus is a software option for the Puritan Bennett 840 Ventilator th… | 2005 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 27 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K103578 (Respironics Novametrix, LLC, 2011) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K021573.
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 Puritan Bennett 840 ventilator with Proportional Assist Ventilation® Plus (PAV+) software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (JEW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive.
PAV+ is intended for use in hospitals and hospital-type facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053388: Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053388
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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