510(k) · Cleared
ClearedIvent 2001 Mri Conditional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Versamed Medical Systems, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on May 30, 2008 as substantially equivalent to K061627 (Versamed Medical Systems, Inc., 2006) and 1 other predicate after a 151-day review. Its family tree reaches back 10 generations to 1991. 7 of the 65 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- May 30, 2008
- Review
- 151 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K902859 (1991). 58 ancestors in all, the oldest K883038 (1988). 6 later devices descend from it, 3 citing it directly. 7 of the 65 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations between
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- This deviceK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK090888 Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK083688 Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc. · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK111146 Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK240807 VM-2000Ventis Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK202970 Ventway SparrowInovytech Medical Solutions, Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 8 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 7 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 6 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 5 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 4 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- This deviceK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · cites it directly2descendants
- K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc. · 2009 · cites it directly2descendants
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · cites it directly1descendant
- K240807VM-2000Ventis Medical, Inc. · 2024 · 2 generations on0descendants
- K202970Ventway SparrowInovytech Medical Solutions, Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −9 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −8 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −7 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −6 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −5 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −3 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| 0 (this device) | K073694 | Ivent 2001 Mri Conditional | Versamed Medical Systems, Inc. | 2008 | — |
| +1 | K090888 | Newport HT70 Family of Ventilators | Newport Medical Instruments, Inc. | 2009 | Class I |
| +1 | K083688 | Pulmonetic Systems LTV 1200 MR Conditional Ventilator | Pulmonetic Systems, Inc. | 2009 | 1 |
| +1 | K111146 | Newport HT70 Ventilator | Newport Medical Instruments, Inc. | 2011 | Class I |
| +2 | K240807 | VM-2000 | Ventis Medical, Inc. | 2024 | — |
| +2 | K202970 | Ventway Sparrow | Inovytech Medical Solutions, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 2 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 1 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 1 |
| 2011 | 1 | 1 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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.
7 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 |
|---|---|---|---|
| * | K061627 | Modification to I Vent 201Summary page 1…Ventilator, continuous, facility use Device: iVentTM 201 MR Conditional Predicate Devices: VersaMed iVentTM 201 - K061627 Maquet SERVO-I - K063404 Device Description: The iVentTM 201 MR Conditional is a compact,… | 2006 |
| * | K063404 | Servo-I Ventilator System, Models 64, 87 and 800Summary page 1…iVentTM 201 MR Conditional Predicate Devices: VersaMed iVentTM 201 - K061627 Maquet SERVO-I - K063404 Device Description: The iVentTM 201 MR Conditional is a compact, portable, fully featured, microprocessor- controlled ventilato… | 2007 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 16 of the 58 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K090888 (Newport Medical Instruments, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K061627.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 iVent TM 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by…
Read the full statement (188 words)
The iVent TM 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician:
Assist/Control (Pressure Controlled or Volume Controlled)
SIMV (Pressure Controlled or Volume Controlled)
CPAP/PSV
The iVentTM 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVentT M 201 MR Conditional ventilator is MR Conditional.
The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments.
The iVentTM 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073694 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073694: Ivent 2001 Mri Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073694
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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