510(k) · Cleared
Recalled · 2009Esprit Ventilator Neonatal 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 Jul 8, 2005 as substantially equivalent to K001646 (Puritan Bennett Corp., 2000) and 3 other predicates after a 53-day review. Its family tree reaches back 5 generations to 1991. 2 of the 16 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Jul 8, 2005
- Review
- 53 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K902859 (1991). 15 ancestors in all, the oldest K864394 (1986). No later device cites it as a predicate yet. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 4 generations backK961687 EVITA 4Drager, Inc. · 1996
- 3 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 2 generations backK984379 Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 1998 · Recalled
- 1 generation backK021112 Inspiration Ventilator SystemeVent Medical, Ltd. · 2002
- This deviceK051262 Esprit Ventilator Neonatal Option, Model V1000Respironics California, Inc. · 2005
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −4 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −3 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −2 | K984379 | Nellcor Puritan Bennett, 760 Ventilator System | Puritan Bennett Corp. | 1998 | 4 |
| −1 | K021112 | Inspiration Ventilator System | eVent Medical, Ltd. | 2002 | — |
| 0 (this device) | K051262 | Esprit Ventilator Neonatal Option, Model V1000 | Respironics California, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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.
2 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 |
|---|---|---|---|
| * | K001646 | Puritan-Bennett 840 Ventilator System with Neomode OptionSummary page 1…Class II Continuous Ventilator (per 21 CFR 868.5895) Predicate * P-B 840 Ventilator NeoMode Option K001646 Devices: D Event Medical Inspiration Ventilator K021112 * Siemens Se… | 2000 |
| * | K021112 | Inspiration Ventilator SystemSummary page 1…68.5895) Predicate * P-B 840 Ventilator NeoMode Option K001646 Devices: D Event Medical Inspiration Ventilator K021112 * Siemens Servo 300 Ventilator K970839 * Drrger Evi… | 2002 |
| * | K970839 | Servo Ventilator 300ASummary page 1…K001646 Devices: D Event Medical Inspiration Ventilator K021112 * Siemens Servo 300 Ventilator K970839 * Drrger Evita 4 Ventilator NeoFlow K983219 Option 1… | 1997 |
| * | K983219 | Neoflow Option Model Numbers 8413563, 8411900Summary page 1…K021112 * Siemens Servo 300 Ventilator K970839 * Drrger Evita 4 Ventilator NeoFlow K983219 Option 16.1 Device Description: The Neonatal Option is a software modificatio… | 1998 |
| † | K981072 | Esprit Ventilator | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
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 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
- 4 other devices also cite its predicate K001646.
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 intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 - 4.0 mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051262: Esprit Ventilator Neonatal 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/K051262
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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