510(k) · Cleared
Recalled · Class I · 2014Esprit Ventilator
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 Nov 12, 1998 after a 233-day review. The FDA summary names its predicate without a number. 45 of the 146 devices in its family, counting itself, have a Class I recall. 145 later devices descend from it. It has been recalled 11 times, including a Class I recall.
- Decided
- Nov 12, 1998
- Review
- 233 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 11 (1 Class I)
- Predicates
- 0
145 later devices descend from it, 10 citing it directly. 45 of the 146 devices in this family, counting this one, have a Class I recall.
- This deviceK981072 Esprit VentilatorRespironics, Inc. · 1998
- Descendant · cites it directly · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 2 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 3 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- Descendant · 4 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 145 · See all- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · cites it directly114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 2 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 2 generations on87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 3 generations on86descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 4 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981072 | Esprit Ventilator | Respironics, Inc. | 1998 | — |
| +1 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +2 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +2 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +4 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 1 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 1 |
| 2008 | 6 | 1 |
| 2009 | 8 | 3 |
| 2010 | 6 | 2 |
| 2011 | 13 | 8 |
| 2012 | 14 | 4 |
| 2013 | 10 | 4 |
| 2014 | 6 | 1 |
| 2015 | 8 | 1 |
| 2016 | 8 | 3 |
| 2017 | 10 | 4 |
| 2018 | 3 | 1 |
| 2019 | 8 | 3 |
| 2020 | 4 | 3 |
| 2021 | 6 | 3 |
| 2022 | 2 | 0 |
| 2023 | 3 | 1 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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.
45 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? (3)
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 |
|---|---|---|---|
| * | — | 7200 ventilator Named without a submission number | |
| * | — | BIRD Tbird Named without a submission number | |
| * | — | Siemens SY300 Named without a submission number |
What descends from it? (145)
See all 14510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032451 | Bird Tbird Vela Ventilator | 2004 | 114 |
| K022750 | PLV Continuum Ventilator, Model P1000 | 2003 | 29 |
| K082660 | V60 Ventilator, Model V8000 Class I | 2009 | 14 |
| K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 | 2007 | 6 |
| K102054 | V200 Ventilator | 2010 | 2 |
| K034032 | PLV Continuum Ventilator, Model P2000 | 2004 | 1 |
| K034040 | Esprit Ventilator, Model V1000 Class I | 2004 | 1 |
| K110083 | V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode | 2012 | 0 |
| K071212 | Esprit Ventilator Speaking Mode Option, Model V1000 | 2007 | 0 |
| K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | 2004 | 0 |
Has anything in its family been recalled? (45 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. |
| Aug 8, 2006 | Not classified | Z-0047-2007 | Other | This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power… |
| Feb 20, 2002 | Not classified | Z-1230-04 | Other | Flow sensors would exhibit drift. |
| Jun 8, 2001 | Not classified | Z-0951-03 | Other | Material hardness on original design check valve may cause premature failure. |
| Jun 1, 2001 | Not classified | Z-0903-04 | Other | Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue. |
The 5 latest of 11 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.
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 44 shown.
Nearest 5 of 44; all are on the web page.
What does this lineage say?
- Of its descendants, K032451 (Bird Products Corp., 2004) has gone furthest, with 114 descendants of its own.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981072: Esprit Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981072
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