510(k) · Cleared
ClearedModification to I Vent 201
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 Jun 29, 2006 as substantially equivalent to K053270 (Versamed Medical Systems, Inc., 2006) after a 17-day review. Its family tree reaches back 8 generations to 1991. 35 of the 128 devices in its family, counting itself, have a Class I recall. 86 later devices descend from it.
- Decided
- Jun 29, 2006
- Review
- 17 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K902859 (1991). 41 ancestors in all, the oldest K883038 (1988). 86 later devices descend from it, 7 citing it directly. 35 of the 128 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 6 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 5 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 4 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 3 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 2 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 1 generation backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- This deviceK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- Descendant · cites it directly · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- Descendant · 2 generations on · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- Descendant · 2 generations on · 28 of its ownK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- Descendant · 2 generations on · 21 of its ownK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- Descendant · 3 generations on · 14 of its ownK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 86 · See all- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · cites it directly61descendants
- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · 2 generations on37descendants
- K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB · 2008 · 2 generations on28descendants
- K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · 2 generations on21descendants
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −6 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −5 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −4 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −2 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −1 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| +2 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| +2 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| +3 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 2 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 1 |
| 2010 | 2 | 0 |
| 2011 | 9 | 7 |
| 2012 | 5 | 2 |
| 2013 | 9 | 4 |
| 2014 | 4 | 1 |
| 2015 | 6 | 1 |
| 2016 | 4 | 2 |
| 2017 | 7 | 4 |
| 2018 | 1 | 0 |
| 2019 | 6 | 3 |
| 2020 | 4 | 3 |
| 2021 | 6 | 3 |
| 2023 | 1 | 1 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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.
35 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? (1)
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 |
|---|---|---|---|
| * | K053270 | IVENT 201Summary page 2…Classification: CBK, DQA, NOU. Predicate Devices: The iVentTM 201 Portable Ventilator is substantially equivalent to: iVentTM cleared under K053270 Performance Standards: No performance standards have been established for such devices under Sections 514 of the Fed… | 2006 |
What descends from it? (86)
See all 867 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | 2007 | 61 |
| K111610 | Trilogy Series Ventilator with Oximetry Class I | 2011 | 11 |
| K082724 | Newport HTS50 Ventilator with Dual Pac Battery System | 2008 | 9 |
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMV | 2008 | 7 |
| K073694 | Ivent 2001 Mri Conditional | 2008 | 6 |
| K090888 | Newport HT70 Family of Ventilators Class I | 2009 | 2 |
| K081845 | IVENT101 | 2009 | 0 |
Has anything in its family been recalled? (35 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 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 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
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
Nearest 12 of 35 shown.
Nearest 5 of 35; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 41 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K063404 (Maquet Critical Care AB, 2007) has gone furthest, with 61 descendants of its own.
- 2 other devices also cite its predicate K053270.
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 iVentrF t 201 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 the following general modes of ventilatory support, as prescribed by an attending physician: * Assist/Control (Pressure…
Read the full statement (159 words)
The iVentrF t 201 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 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 iVelzdLM 201 ventilator (with or without the non-invasive Pulse Oximeter option) is suitable for use in the ICU and all other hospital areas. in all hospital-type facilities. alternate-care sites, transport, emergency and in the home environment. The 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.
The i VentIt 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061627 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061627: Modification to I Vent 201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061627
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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