510(k) · Cleared
ClearedInbentus Versatile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iconic Solutions by Murcia, SL · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 14, 2026 as substantially equivalent to K201658 (Hamilton Medical AG, 2020) after a 235-day review. Its family tree reaches back 17 generations to 1991. 15 of the 124 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 14, 2026
- Review
- 235 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K902859 (1991). 123 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet. 15 of the 124 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 13 generations between
- 3 generations backK123637 Hamilton-C3Hamilton Medical AG · 2012
- 2 generations backK161450 Hamilton-C3Hamilton Medical AG · 2017 · Recalled
- 1 generation backK201658 Hamilton-C6Hamilton Medical AG · 2020 · Recalled (Class I)
- This deviceK252663 Inbentus VersatileIconic Solutions by Murcia, SL · 2026
Show all 17 generations
- Root · 17 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 16 generations backK961687 EVITA 4Drager, Inc. · 1996
- 15 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 14 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 13 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 12 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 11 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 10 generations backK061090 Galileo Gold AsvHamilton Medical AG · 2006
- 9 generations backK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- 8 generations backK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- 7 generations backK102775 Hamilton-C2Hamilton Medical AG · 2011
- 6 generations backK112006 Hamilton-TC1Hamilton Medical AG · 2012
- 5 generations backK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- 4 generations backK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- 3 generations backK123637 Hamilton-C3Hamilton Medical AG · 2012
- 2 generations backK161450 Hamilton-C3Hamilton Medical AG · 2017 · Recalled
- 1 generation backK201658 Hamilton-C6Hamilton Medical AG · 2020 · Recalled (Class I)
- This deviceK252663 Inbentus VersatileIconic Solutions by Murcia, SL · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −16 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −15 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −14 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −13 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −12 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −11 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −10 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| −9 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| −8 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| −7 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| −6 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| −5 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| −4 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| −3 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
| −2 | K161450 | Hamilton-C3 | Hamilton Medical AG | 2017 | 2 |
| −1 | K201658 | Hamilton-C6 | Hamilton Medical AG | 2020 | Class I |
| 0 (this device) | K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 10 | 1 |
| 1999 | 9 | 0 |
| 2000 | 4 | 1 |
| 2001 | 6 | 0 |
| 2002 | 5 | 1 |
| 2003 | 4 | 1 |
| 2004 | 10 | 1 |
| 2005 | 3 | 0 |
| 2006 | 6 | 1 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2010 | 3 | 1 |
| 2011 | 1 | 1 |
| 2013 | 1 | 1 |
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.
15 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 K232365 Vivo 45 LSscore 14.4 · 14 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 |
|---|---|---|---|
| * | K201658 | Hamilton-C6Summary page 4…S VERSATILE is substantially equivalent to the following predicate device: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K201658 Hamilton-C6 / Hamilton Medical AG DEVICE DESCRIPTION The INBENTUS VERSATILE is… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (15 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.
- K201658Hamilton-C6Hamilton Medical AG · 2020 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations back · ◆ in the 2013 ancestors bar of FIG. 12 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 7 generations back · ◆ in the 2006 ancestors bar of FIG. 13 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 8 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
Nearest 12 of 15 shown.
Nearest 5 of 15; all are on the web page.
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 40 of the 123 ancestors have a recall of any class; 15 have a Class I recall.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 INBENTUS VERSATILE ventilator is intended to provide invasive and noninvasive ventilatory support to adult, pediatric, and neonatal patients. It is only intended for use by qualified health care personnel, within professional hospital facilities and to transport patients within those facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252663: Inbentus Versatile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252663
Report an extraction error
Are you the manufacturer?
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