510(k) · Cleared
ClearedVM-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventis Medical, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Aug 13, 2024 as substantially equivalent to K083688 (Pulmonetic Systems, Inc., 2009) and 1 other predicate after a 141-day review. Its family tree reaches back 13 generations to 1996. 18 of the 189 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 13, 2024
- Review
- 141 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K953930 (1996). 188 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 18 of the 189 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 9 generations between
- 3 generations backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 2 generations backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 1 generation backK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- This deviceK240807 VM-2000Ventis Medical, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 12 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 11 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 10 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 9 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 8 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 7 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 6 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 5 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 4 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 3 generations backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 2 generations backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 1 generation backK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- This deviceK240807 VM-2000Ventis Medical, Inc. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −12 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −11 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −10 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −9 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −8 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −7 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −6 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −5 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −4 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| −3 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| −2 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| −1 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| 0 (this device) | K240807 | VM-2000 | Ventis Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 6 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 10 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 18 | 2 |
| 1999 | 9 | 0 |
| 2000 | 9 | 1 |
| 2001 | 13 | 0 |
| 2002 | 11 | 1 |
| 2003 | 9 | 1 |
| 2004 | 11 | 1 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 1 |
| 2008 | 5 | 0 |
| 2009 | 6 | 2 |
| 2010 | 3 | 2 |
| 2011 | 3 | 1 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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.
18 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? (2)
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 |
|---|---|---|---|
| * | K083688 | Pulmonetic Systems LTV 1200 MR Conditional VentilatorSummary page 5…868.5895 Product Classification: CBK Primary Predicate Device: Cardinal Health LTV 1200 - K083688 Classification Name: Continuous ventilator CFR: 868.5895 Produc… | 2009 |
| * | K181166 | Trilogy EvoSummary page 5…868.5895 Product Classification: CBK Secondary Predicate Device: Respironics Trilogy EVO – K181166 Classification Name: Continuous ventilator CFR: 868.5895 Produc… | 2019 |
| † | K202970 | Ventway Sparrow | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (18 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.
- K181166Trilogy EvoRespironics, Inc. · 2019 · Direct predicate · ◆ on the line of descent in FIG. 131 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations back · ◆ in the 2017 ancestors bar of FIG. 114 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K093905Trilogy 202 VentilatorRespironics, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 4 generations back · ◆ in the 2009 ancestors bar of FIG. 13 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
Nearest 12 of 18 shown.
Nearest 5 of 18; all are on the web page.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 63 of the 188 ancestors have a recall of any class; 18 have a Class I recall.
- 1 other device also cites its predicate K083688.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
- Assist/Control, SIMV, CPAP and NPPV modes of ventilation.
The ventilator is suitable for use in institutional or transport settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240807: VM-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240807
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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