510(k) · Cleared
Recalled · Class II · 2018Hamilton-C3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Medical AG · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 27, 2017 as substantially equivalent to K123637 (Hamilton Medical AG, 2012) and 1 other predicate after a 337-day review. Its family tree reaches back 15 generations to 1991. 16 of the 125 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 27, 2017
- Review
- 337 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 15 generations to K902859 (1991). 121 ancestors in all, the oldest K791045 (1979). 3 later devices descend from it, 2 citing it directly. 16 of the 125 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations between
- 3 generations backK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- 2 generations backK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- 1 generation backK123637 Hamilton-C3Hamilton Medical AG · 2012
- This deviceK161450 Hamilton-C3Hamilton Medical AG · 2017
- Descendant · cites it directly · 1 of its ownK201658 Hamilton-C6Hamilton Medical AG · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK252663 Inbentus VersatileIconic Solutions by Murcia, SL · 2026
- Descendant · cites it directly · 0 of its ownK201306 Hamilton-C3Hamilton Medical AG · 2021 · Recalled (Class I)
Show all 15 generations
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 14 generations backK961687 EVITA 4Drager, Inc. · 1996
- 13 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 12 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 11 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 10 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 9 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 8 generations backK061090 Galileo Gold AsvHamilton Medical AG · 2006
- 7 generations backK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- 6 generations backK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- 5 generations backK102775 Hamilton-C2Hamilton Medical AG · 2011
- 4 generations backK112006 Hamilton-TC1Hamilton Medical AG · 2012
- 3 generations backK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- 2 generations backK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- 1 generation backK123637 Hamilton-C3Hamilton Medical AG · 2012
- This deviceK161450 Hamilton-C3Hamilton Medical AG · 2017
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −14 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −13 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −12 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −11 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −10 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −9 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −8 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| −7 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| −6 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| −5 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| −4 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| −3 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| −2 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| −1 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
| 0 (this device) | K161450 | Hamilton-C3 | Hamilton Medical AG | 2017 | — |
| +1 | K201658 | Hamilton-C6 | Hamilton Medical AG | 2020 | Class I |
| +2 | K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026 | — |
| +1 | K201306 | Hamilton-C3 | Hamilton Medical AG | 2021 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2026 | 1 | 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.
16 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 |
|---|---|---|---|
| * | K123637 | Hamilton-C3Summary page 4…d Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK (subsequent: DQA) III. PREDICATE DEVICES HAMILTON-C3 (K123637) HAMILTON-G5 (K131774) IV. DEVICE DESCRIPTION The HAMILTON-C3 is designed for adult, paediatric, infant, and n… | 2012 |
| * | K131774 | Hamilton-G5Summary page 4…s (21 CFR 868.5895) Device Classification: 2 Product Code: CBK (subsequent: DQA) III. PREDICATE DEVICES HAMILTON-C3 (K123637) HAMILTON-G5 (K131774) IV. DEVICE DESCRIPTION The HAMILTON-C3 is designed for adult, paediatric, infant, and neonatal patients requi… | 2013 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (16 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2018 | Class II | Z-1372-2018 | Other | After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. |
| Mar 9, 2018 | Class II | Z-2796-2018 | Nonconforming Material/Component | An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking… |
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.
- K131774Hamilton-G5Hamilton Medical AG · 2013 · Direct predicate · ◆ in the 2013 ancestors bar of FIG. 12 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 3 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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 4 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 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 5 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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
Nearest 12 of 16 shown.
Nearest 5 of 16; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 38 of the 121 ancestors have a recall of any class; 14 have a Class I recall.
- Of its descendants, K201658 (Hamilton Medical AG, 2020) has gone furthest, with 1 descendant 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. 2017, 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 HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161450: Hamilton-C3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161450
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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