510(k) · Cleared
ClearedEsprit Ventilator Auto-Trak Sensitivity 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 Dec 12, 2007 as substantially equivalent to K981072 (Respironics, Inc., 1998) and 2 other predicates after a 103-day review. Its family tree reaches back 4 generations to 1983. 1 of the 17 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Dec 12, 2007
- Review
- 103 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K833786 (1983). 10 ancestors in all, the oldest K811102 (1981). 6 later devices descend from it, 1 citing it directly. 1 of the 17 devices in this family, counting this one, has 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 deviceK072450 Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · 2 generations on · 3 of its ownK101129 Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK150638 AF541 SE Full Face MaskRespironics, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK251888 VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK243394 AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K981072 Esprit Ventilatordirect predicate · 1998
Most influential descendants
Showing 5 of 6 · See all- K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly5descendants
- K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010 · 2 generations on3descendants
- K150638AF541 SE Full Face MaskRespironics, Inc. · 2015 · 3 generations on1descendant
- K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026 · 3 generations on0descendants
- K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024 · 3 generations on0descendants
View 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) | K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 | Respironics California, Inc. | 2007 | — |
| +1 | K092648 | Respironics Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +2 | K101129 | Esprit Ventilator with AF531 SE Full Face Mask | Respironics, Inc. | 2010 | — |
| +3 | K150638 | AF541 SE Full Face Mask | Respironics, Inc. | 2015 | — |
| +3 | K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026 | — |
| +3 | K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K981072 | Esprit VentilatorSummary page 1…Product Code: 73 - CBK Panel: Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (73) Predicate Device: Esprit Ventilator (K981072) Vision Ventilator with Auto-Trak (K982454) Evita XL Ventilator with "Option Mask Ventilation NIV" (K980642) Indic… | 1998 |
| * | K982454 | Bipap Vision Ventilatory SupportSummary page 1…iology, General Hospital, Infection Control and Dental Devices (73) Predicate Device: Esprit Ventilator (K981072) Vision Ventilator with Auto-Trak (K982454) Evita XL Ventilator with "Option Mask Ventilation NIV" (K980642) Indications for Use: The ESPRIT ventilator is a micropr… | 1998 |
| * | K980642 | EVITA 4 (8411900)Summary page 1…3) Predicate Device: Esprit Ventilator (K981072) Vision Ventilator with Auto-Trak (K982454) Evita XL Ventilator with "Option Mask Ventilation NIV" (K980642) Indications for Use: The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is i… | 1998 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092648 | Respironics Performax SE Total Face Mask | 2009 | 5 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K981072Esprit VentilatorRespironics, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K092648 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 5 descendants of its own.
- 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. 2007, this device’s year, is highlighted.
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, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Auto-Trak option is intended for adult and pediatric patients, and…
Read the full statement (94 words)
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, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for user-adjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072450: Esprit Ventilator Auto-Trak Sensitivity Option, 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/K072450
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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