510(k) · Cleared
ClearedSmartvent 201 Portable Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Versamed, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 7, 1999 as substantially equivalent to K950484 (Bird Products Corp., 1996) and 1 other predicate after a 331-day review. Its family tree reaches back 1 generation to 1995. 45 of the 139 devices in its family, counting itself, have a Class I recall. 136 later devices descend from it.
- Decided
- Apr 7, 1999
- Review
- 331 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943531 (1995). 2 ancestors in all. 136 later devices descend from it, 4 citing it directly. 45 of the 139 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK943531 Oxylog 2000Drager, Inc. · 1995
- This deviceK981668 Smartvent 201 Portable VentilatorVersamed, Ltd. · 1999
- Descendant · cites it directly · 134 of its ownK011957 Ivent 201 Portable VentilatorVersamed, Ltd. · 2001
- Descendant · 2 generations on · 123 of its ownK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
- Descendant · 3 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 4 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 5 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 136 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 136 · See all- K011957Ivent 201 Portable VentilatorVersamed, Ltd. · 2001 · cites it directly134descendants
- K042468Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004 · 2 generations on123descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 3 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 4 generations on87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 5 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943531 | Oxylog 2000 | Drager, Inc. | 1995 | — |
| 0 (this device) | K981668 | Smartvent 201 Portable Ventilator | Versamed, Ltd. | 1999 | — |
| +1 | K011957 | Ivent 201 Portable Ventilator | Versamed, Ltd. | 2001 | — |
| +2 | K042468 | Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2004 | — |
| +3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +5 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 1 |
| 2007 | 2 | 1 |
| 2008 | 7 | 2 |
| 2009 | 5 | 1 |
| 2010 | 4 | 1 |
| 2011 | 13 | 8 |
| 2012 | 13 | 5 |
| 2013 | 10 | 4 |
| 2014 | 7 | 1 |
| 2015 | 9 | 2 |
| 2016 | 7 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 8 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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.
45 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 |
|---|---|---|---|
| * | K950484 | Tbird VS Ventilator and Tbird Avs VentilatorSummary page 5…Predicate Devices: The SmartVent™ 201 Portable Ventilator is substantially equivalent to: e TBIRD VS & AVS Ventilators (Bird Product Co.), cleared under K950484 e Oxylog 2000 (Dréger, Inc.), cleared under K943531. Performance Standards: No performance standards have been established for… | 1996 |
| * | K943531 | Oxylog 2000Summary page 5…01 Portable Ventilator is substantially equivalent to: e TBIRD VS & AVS Ventilators (Bird Product Co.), cleared under K950484 e Oxylog 2000 (Dréger, Inc.), cleared under K943531. Performance Standards: No performance standards have been established for such devices under Sections 514 of the Federal Food,… | 1995 |
What descends from it? (136)
See all 1364 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (45 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.
- 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 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K152068Astral 100/150Resmed, Ltd. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 112 Class I recalls
Nearest 12 of 45 shown.
Nearest 5 of 45; all are on the web page.
What does this lineage say?
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 SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 1b.), who require the following general modes of ventilatory support, as prescribed by an attending physician: ® Assist/Control…
Read the full statement (121 words)
The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 1b.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
® Assist/Control (Pressure Controlled or Volume Controlled)
e SIMV (Pressure Controlled or Volume Controlled)
e CPAP/PSV
The SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
The SmartVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981668: Smartvent 201 Portable Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981668
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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