510(k) · Cleared
Recalled · Class I · 2019Hamilton-G5
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 Nov 23, 2011 as substantially equivalent to K092148 (Hamilton Medical AG, 2010) and 5 other predicates after a 330-day review. Its family tree reaches back 11 generations to 1991. 15 of the 106 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- Nov 23, 2011
- Review
- 330 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4 (1 Class I)
- Predicates
- 6
Its longest line of descent runs back 11 generations to K902859 (1991). 91 ancestors in all, the oldest K791045 (1979). 14 later devices descend from it, 3 citing it directly. 15 of the 106 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations between
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- This deviceK103803 Hamilton-G5Hamilton Medical AG · 2011
- Descendant · cites it directly · 10 of its ownK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- Descendant · cites it directly · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK123637 Hamilton-C3Hamilton Medical AG · 2012
- Descendant · 2 generations on · 3 of its ownK161450 Hamilton-C3Hamilton Medical AG · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK180295 Hamilton-G5Hamiton Medical AG · 2019
Show all 11 generations
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 4 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- This deviceK103803 Hamilton-G5Hamilton Medical AG · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K041223 Modification to Servo-I Ventilator System, Model…2 generations back · 2004
- K001646 Puritan-Bennett 840 Ventilator System with…4 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…4 generations back · 1998
- K023366 Datex-Ohmeda 7900 Ventilator Enhancements5 generations back · 2003
Most influential descendants
Showing 5 of 14 · See all- K131774Hamilton-G5Hamilton Medical AG · 2013 · cites it directly10descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · cites it directly8descendants
- K123637Hamilton-C3Hamilton Medical AG · 2012 · 2 generations on4descendants
- K161450Hamilton-C3Hamilton Medical AG · 2017 · 2 generations on3descendants
- K180295Hamilton-G5Hamiton Medical AG · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −10 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −9 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −8 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −7 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −6 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −5 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −1 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| 0 (this device) | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | — |
| +1 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | Class I |
| +1 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| +2 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
| +2 | K161450 | Hamilton-C3 | Hamilton Medical AG | 2017 | 2 |
| +2 | K180295 | Hamilton-G5 | Hamiton Medical AG | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 3 |
| 1999 | 6 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 1 |
| 2004 | 6 | 1 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 1 |
| 2013 | 2 | 2 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2019 | 2 | 1 |
| 2020 | 2 | 1 |
| 2021 | 1 | 1 |
| 2024 | 1 | 0 |
| 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.
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 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? (6)
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 |
|---|---|---|---|
| * | K092148 | Hamilton-C2Summary page 1…tinuous, Facility Use (21 CFR 868.5895, Product Code: CBK) Legally marketed devices to HAMILTON-C2 (K092148) HAMILTON-GALILEO (KO80l81) which equivalence is being Dri… | 2010 |
| * | K080181 | Modification to Galileo Gold | 2008 |
| * | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Summary page 1…AMILTON-GALILEO (KO80l81) which equivalence is being Driger EvitaXL with NeoFlow and SpO2 clamed: options (K072412, K983219) ARM PYTON ETT Cuff Pressure Regulator… | 2008 |
| * | K983219 | Neoflow Option Model Numbers 8413563, 8411900Summary page 1…ALILEO (KO80l81) which equivalence is being Driger EvitaXL with NeoFlow and SpO2 clamed: options (K072412, K983219) ARM PYTON ETT Cuff Pressure Regulator… | 1998 |
| * | K092733 | PYTONSummary page 1…options (K072412, K983219) ARM PYTON ETT Cuff Pressure Regulator (K092733) GE Datex-Ohmedla Engstrdm Carestation… | 2010 |
| * | K081842 | Engstrom Carestation, Engstrom ProSummary page 1…(K092733) GE Datex-Ohmedla Engstrdm Carestation (K081842) Device Description The HAMILTON-G5 is an electronically controlled pneumatic intensive care ventilator ventilation system. i… | 2008 |
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (15 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2019 | Class I | Z-1874-2019 | Software design | New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When… |
| Mar 9, 2016 | Class II | Z-1624-2016 | Software design | After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected. |
| Mar 24, 2015 | Class II | Z-2057-2015 | Device Design | Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device. |
| Feb 6, 2012 | Not classified | Z-1185-2012 | Software design | Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions. |
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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 6 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 26 of the 91 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K131774 (Hamilton Medical AG, 2013) has gone furthest, with 10 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. 2011, 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-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients.
The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility transport, provided compressed gas is supplied.
The device is not intended for transportation outside the hospital or for use in the home environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103803: Hamilton-G5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103803
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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