510(k) · Cleared
ClearedIVENT101
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 Jun 15, 2012 as substantially equivalent to K092135 (Versamed Medical Systems, Ltd., 2009) and 1 other predicate after a 268-day review. Its family tree reaches back 6 generations to 1991. 6 of the 43 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Jun 15, 2012
- Review
- 268 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K902859 (1991). 33 ancestors in all, the oldest K841279 (1984). 9 later devices descend from it, 1 citing it directly. 6 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK961687 EVITA 4Drager, Inc. · 1996
- 4 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 3 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 2 generations backK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- 1 generation backK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- This deviceK112754 IVENT101Versamed Medical Systems, Ltd. · 2012
- Descendant · cites it directly · 8 of its ownK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- Descendant · 2 generations on · 7 of its ownK160481 Vivo 60Breas Medical AB · 2016 · Recalled
- Descendant · 3 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K123144VIVO 50Ge Healthcare, Breas Medical AB · 2013 · cites it directly8descendants
- K160481Vivo 60Breas Medical AB · 2016 · 2 generations on7descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on2descendants
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −4 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −3 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −2 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| −1 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| 0 (this device) | K112754 | IVENT101 | Versamed Medical Systems, Ltd. | 2012 | — |
| +1 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| +2 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 2 |
| +3 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +3 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +4 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 1 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
6 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 |
|---|---|---|---|
| * | K092135 | Modification to Ivent 101Summary page 1…Common/Usual Portable Ventilator Name: Classification Names: 868-5895, Continuous Ventilator Product Code: 73 CBK. 73 NOU Predicate Devicels). iVent101 [cleared under K092135] Trilogy 100 [cleared under K083526] GE Healthcare, VersaMed Medical Systems 23 of 2739 Page 2 of 3 Device 1he… | 2009 |
| * | K083526 | Trilogy 100 VentilatorSummary page 1…: Classification Names: 868-5895, Continuous Ventilator Product Code: 73 CBK. 73 NOU Predicate Devicels). iVent101 [cleared under K092135] Trilogy 100 [cleared under K083526] GE Healthcare, VersaMed Medical Systems 23 of 2739 Page 2 of 3 Device 1he jvent101 is a compact, portable, mic… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123144 | VIVO 50 | 2013 | 8 |
Has anything in its family been recalled? (6 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.
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 15 of the 33 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K123144 (Ge Healthcare, Breas Medical AB, 2013) has gone furthest, with 8 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. 2012, 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 iVent101 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…
Read the full statement (103 words)
The iVent101 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 and CPAP / Pressure Support Volume Guaranteed [VG)
Adaptive Bi-Level for either NIV or invasive ventilation and Adaptive Bi-Level Volume Guaranteed [VG]
The iVent101 ventilator is suitable for use in institution, home and portable settings
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/K112754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112754: IVENT101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112754
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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