510(k) · Cleared
Recalled · Class I · 2014Esprit Ventilator, Model V1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 21, 2004 as substantially equivalent to K023350 (Respironics California, Inc., 2002) and 3 other predicates after a 23-day review. Its family tree reaches back 5 generations to 1983. 5 of the 29 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 8 times, including a Class I recall.
- Decided
- Jan 21, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 8 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 5 generations to K833786 (1983). 27 ancestors in all, the oldest K811102 (1981). 1 later device descends from it, 1 citing it directly. 5 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 4 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 3 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 2 generations backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- 1 generation backK023350 Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · Recalled (Class I)
- This deviceK034040 Esprit Ventilator, Model V1000Respironics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK041412 Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc. · 2004 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −4 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −3 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −2 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| −1 | K023350 | Esprit Ventilator with Respiratory Mechanics | Respironics California, Inc. | 2002 | Class I |
| 0 (this device) | K034040 | Esprit Ventilator, Model V1000 | Respironics, Inc. | 2004 | — |
| +1 | K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | Respironics California, Inc. | 2004 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 2 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
5 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 |
|---|---|---|---|
| * | K023350 | Esprit Ventilator with Respiratory MechanicsSummary page 1…Diagnostic Spirometer per 21 CFR 868.1 Procode: CBK and BZG Predicate Devices: Esprit Ventilator (K023350/K981072) Bear 1000 Ventilator (K912619/A) Servo' Ventilator… | 2002 |
| * | K981072 | Esprit VentilatorSummary page 1…Diagnostic Spirometer per 21 CFR 868.1 Procode: CBK and BZG Predicate Devices: Esprit Ventilator (K023350/K981072) Bear 1000 Ventilator (K912619/A) Servo' Ventilator System… | 1998 |
| * | K912619 | Bear 7 VentilatorSummary page 1…Procode: CBK and BZG Predicate Devices: Esprit Ventilator (K023350/K981072) Bear 1000 Ventilator (K912619/A) Servo' Ventilator System (K022132) Description of Device Modification: The VCV D… | 1992 |
| * | K022132 | Servo Ventilator System, Model 64 87 800 E407ESummary page 1…Esprit Ventilator (K023350/K981072) Bear 1000 Ventilator (K912619/A) Servo' Ventilator System (K022132) Description of Device Modification: The VCV Demand Flow Option is a software option for the currently marketed E… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | 2004 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2014 | Class II | Z-0485-2015 | Device Design | If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if… |
| Sep 17, 2014 | Class I | Z-0008-2015 | Unknown/Undetermined by firm | A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not… |
| Apr 22, 2009 | Not classified | Z-1813-2009 | Device Design | The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted… |
| Jan 25, 2008 | Not classified | Z-2002-2008 | Device Design | This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize… |
| Jan 25, 2008 | Not classified | Z-2003-2008 | Device Design | This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize… |
| Jan 25, 2008 | Not classified | Z-2004-2008 | Device Design | This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize… |
| Oct 29, 2007 | Class II | Z-2084-2013 | Device Design | The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable. |
| Feb 20, 2002 | Not classified | Z-1230-04 | Other | Flow sensors would exhibit drift. |
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.
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 27 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K041412 (Respironics California, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023350.
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 Esprit Ventilator with VCV Demand Flow Option is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034040: Esprit Ventilator, Model V1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034040
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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