510(k) · Cleared
ClearedModification to Ivent 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Versamed Medical Systems, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 23, 2009 after a 131-day review. The FDA summary names no predicate by number. 3 of the 11 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.
- Decided
- Nov 23, 2009
- Review
- 131 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly. 3 of the 11 devices in this family, counting this one, have a Class I recall.
- This deviceK092135 Modification to Ivent 101Versamed Medical Systems, Ltd. · 2009
- Descendant · cites it directly · 9 of its ownK112754 IVENT101Versamed Medical Systems, Ltd. · 2012
- Descendant · 2 generations on · 8 of its ownK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- Descendant · 3 generations on · 7 of its ownK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- Descendant · 4 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 4 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K112754IVENT101Versamed Medical Systems, Ltd. · 2012 · cites it directly9descendants
- K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013 · 2 generations on8descendants
- K160481Vivo 60Breas Medical AB · 2016 · 3 generations on7descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092135 | Modification to Ivent 101 | Versamed Medical Systems, Ltd. | 2009 | — |
| +1 | K112754 | IVENT101 | Versamed Medical Systems, Ltd. | 2012 | — |
| +2 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| +3 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| +4 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +4 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 2 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112754 | IVENT101 | 2012 | 9 |
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.
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
What does this lineage say?
- Of its descendants, K112754 (Versamed Medical Systems, Ltd., 2012) has gone furthest, with 9 descendants of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 iVentl01 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:
* Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated Volume Control (PRVC)
* CPAP with Pressure Support
* Adaptive Bi-Level for either NIV or invasive ventilation.
The iVent101 ventilator is suitable for use in institution, home and portable settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092135: Modification to Ivent 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092135
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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