510(k) · Cleared
Recalled · Class I · 2014Esprit Ventilator with Respiratory Mechanics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics California, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 6, 2002 as substantially equivalent to K902506 (Puritan Bennett Corp., 1991) and 4 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1983. 3 of the 19 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 7 times, including a Class I recall.
- Decided
- Nov 6, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 7 (1 Class I)
- Predicates
- 5
Its longest line of descent runs back 4 generations to K833786 (1983). 16 ancestors in all, the oldest K811102 (1981). 2 later devices descend from it, 2 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 3 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 2 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 1 generation backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- This deviceK023350 Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK034040 Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · Recalled (Class I)
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −3 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −2 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −1 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| 0 (this device) | K023350 | Esprit Ventilator with Respiratory Mechanics | Respironics California, Inc. | 2002 | — |
| +1 | K034040 | Esprit Ventilator, Model V1000 | Respironics, Inc. | 2004 | Class I |
| +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 |
| 1998 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 1 |
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.
3 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? (5)
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…ous Ventilator (per 21 CFR 868.5895) Diagnostic Spirometer (per 21 CFR 868.1840) Predicate Puritan-Bennett 7200a Ventilator K902506 Devices: Puritan-Bennett 840 Ventilator K970460 lnfrasonics Adult Star Ventilator… | 1991 |
| * | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Summary page 1…Spirometer (per 21 CFR 868.1840) Predicate Puritan-Bennett 7200a Ventilator K902506 Devices: Puritan-Bennett 840 Ventilator K970460 lnfrasonics Adult Star Ventilator K905272 Drager Evita 4 Ventilator… | 1998 |
| * | K905272 | Adult Star, ModificationSummary page 1…t 7200a Ventilator K902506 Devices: Puritan-Bennett 840 Ventilator K970460 lnfrasonics Adult Star Ventilator K905272 Drager Evita 4 Ventilator K961687 Respironics BiPAP Vision… | 1991 |
| * | K961687 | EVITA 4Summary page 1…t 840 Ventilator K970460 lnfrasonics Adult Star Ventilator K905272 Drager Evita 4 Ventilator K961687 Respironics BiPAP Vision K982454 Description of Device Modification: Esprit Res… | 1996 |
| * | K982454 | Bipap Vision Ventilatory SupportSummary page 1…ult Star Ventilator K905272 Drager Evita 4 Ventilator K961687 Respironics BiPAP Vision K982454 Description of Device Modification: Esprit Respiratory Mechanics is a diagnostic tool that enables a clinician to take… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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… |
| 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 7 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.
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K034040 (Respironics, Inc., 2004) has gone furthest, with 1 descendant 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 Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for 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/K023350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023350: Esprit Ventilator with Respiratory Mechanics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023350
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