510(k) · Cleared
ClearedV200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode
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 Jan 13, 2012 as substantially equivalent to K981072 (Respironics, Inc., 1998) and 2 other predicates after a 367-day review. Its family tree reaches back 5 generations to 1991. 3 of the 24 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 13, 2012
- Review
- 367 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K902859 (1991). 23 ancestors in all, the oldest K895541 (1990). No later device cites it as a predicate yet. 3 of the 24 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 backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 3 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 2 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 1 generation backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- This deviceK110083 V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv ModeRespironics California, Inc. · 2012
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 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −3 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −2 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −1 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| 0 (this device) | K110083 | V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode | Respironics California, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 2 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 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.
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? (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…s: Manufacturer Device Name 510(k) Number Respironics California, Inc. Esprit Ventilator K98 1072 Respironics California, Inc V200 Ventilator K1 02054 CareFusio… | 1998 |
| * | K102054 | V200 VentilatorSummary page 1…Respironics California, Inc. Esprit Ventilator K98 1072 Respironics California, Inc V200 Ventilator K1 02054 CareFusion Avea Ventilator K0 13642 Intended Use of the Device: The E… | 2010 |
| * | K013642 | AVEASummary page 1…Respironics California, Inc V200 Ventilator K1 02054 CareFusion Avea Ventilator K0 13642 Intended Use of the Device: The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical vent… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K013642AVEABird Products Corp. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 113 Class I recalls
- 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
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 23 ancestors have a recall of any class; 3 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. 2012, 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 and contains the following modes of ventilation: Assist/Control (A/C)…
Read the full statement (208 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 and contains the following modes of ventilation:
Assist/Control (A/C)
Synchronized Intermittent Mandatory Ventilation (SIMV)
Continuous Positive Airway Pressure (CPAP)
Spontaneous (Spont)
Spontaneous/Timed (Spont/T)
Apnea (Backup Mode)
The Esprit Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician.
The V200 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 V200 Ventilator is intended for use in either invasive or non-invasive applications and contains the following modes of ventilation:
Assist/Control (A/C)
Synchronized Intermittent Mandatory Ventilation (SIMV)
Continuous Positive Airway Pressure (CPAP)
Spontaneous (Spont)
Spontaneous/Timed (Spont/T)
Apnea (Backup Mode)
The V200 Ventilator with Airway Pressure Release Ventilation (APRV) Mode is intended for use only on invasively ventilated adult and pediatric patients as prescribed by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110083: V200 Ventilator with Aprv Mode, Esprit Ventilator with Aprv Mode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110083
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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