510(k) · Cleared
Recalled · Class II · 2014Esprit Ventilator with Nico-Esprit Interface Option, Model V1000
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 Jun 18, 2004 as substantially equivalent to K981072 (Respironics, Inc., 1998) and 5 other predicates after a 22-day review. Its family tree reaches back 6 generations to 1997. 6 of the 41 devices in its family, counting itself, have a Class I recall. It has been recalled 6 times.
- Decided
- Jun 18, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 6
- Predicates
- 6
Its longest line of descent runs back 6 generations to K962603 (1997). 40 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 6 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
- This deviceK041412 Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc. · 2004
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | 1 |
| −1 | K030886 | Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2003 | 8 |
| 0 (this device) | K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | Respironics California, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 2 |
| 1999 | 1 | 0 |
| 2000 | 4 | 2 |
| 2001 | 3 | 0 |
| 2002 | 2 | 1 |
| 2004 | 1 | 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.
6 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? (6)
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 |
|---|---|---|---|
| * | K981072 | Esprit VentilatorSummary page 1…ication: Class II Continuous Ventilator (per 21 CFR 868.5895) Predicate Respironics Esprit Ventilator K981072 K001208, Devices: K023350, K034040… | 1998 |
| * | K001208 | EspirtSummary page 1…Class II Continuous Ventilator (per 21 CFR 868.5895) Predicate Respironics Esprit Ventilator K981072 K001208, Devices: K023350, K034040 Infraso… | 2000 |
| * | K023350 | Esprit Ventilator with Respiratory MechanicsSummary page 1…868.5895) Predicate Respironics Esprit Ventilator K981072 K001208, Devices: K023350, K034040 Infrasonics Adult Star Ventilator K964543 NICO Mon… | 2002 |
| * | K034040 | Esprit Ventilator, Model V1000Summary page 1…Predicate Respironics Esprit Ventilator K981072 K001208, Devices: K023350, K034040 Infrasonics Adult Star Ventilator K964543 NICO Monitor… | 2004 |
| * | K964543 | Infrasonics Adult Ventilator Trending OptionSummary page 1…2 K001208, Devices: K023350, K034040 Infrasonics Adult Star Ventilator K964543 NICO Monitor K030886 6.1 Device Description: The… | 1997 |
| * | K030886 | Nico with Mars, Model 7300Summary page 1…K023350, K034040 Infrasonics Adult Star Ventilator K964543 NICO Monitor K030886 6.1 Device Description: The NICO-Esprit Interface is a software upgrade to the Esprit Ventilator, which… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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… |
| 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. |
The 5 latest of 6 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 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K001208EspirtRespironics, Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · Direct predicate · ◆ in the 1998 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
- 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
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 7 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 15 of the 40 ancestors have a recall of any class; 6 have a Class I recall.
- 9 other devices also cite its predicate K981072.
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/K041412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041412: Esprit Ventilator with Nico-Esprit Interface Option, Model V1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041412
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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