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 Oct 9, 2013 as substantially equivalent to K103803 (Hamilton Medical AG, 2011) and 1 other predicate after a 114-day review. Its family tree reaches back 12 generations to 1991. 13 of the 107 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 4 times, including 2 Class I recalls.
- Decided
- Oct 9, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 12 generations to K902859 (1991). 96 ancestors in all, the oldest K791045 (1979). 10 later devices descend from it, 3 citing it directly. 13 of the 107 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations between
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 1 generation backK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- This deviceK131774 Hamilton-G5Hamilton Medical AG · 2013
- Descendant · cites it directly · 3 of its ownK161450 Hamilton-C3Hamilton Medical AG · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK180295 Hamilton-G5Hamiton Medical AG · 2019
- Descendant · cites it directly · 2 of its ownK140939 Hamilton-T1,Hamilton-C1Hamilton Medical AG · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK201658 Hamilton-C6Hamilton Medical AG · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK193228 Hamilton-G5Hamilton Medical AG · 2020
Show all 12 generations
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 10 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 9 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 8 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 7 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 6 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 5 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 1 generation backK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- This deviceK131774 Hamilton-G5Hamilton Medical AG · 2013
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- K161450Hamilton-C3Hamilton Medical AG · 2017 · cites it directly3descendants
- K180295Hamilton-G5Hamiton Medical AG · 2019 · cites it directly2descendants
- K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG · 2015 · cites it directly2descendants
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 2 generations on1descendant
- K193228Hamilton-G5Hamilton Medical AG · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −11 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −10 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −9 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −8 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −7 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −6 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −2 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −1 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
| 0 (this device) | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | — |
| +1 | K161450 | Hamilton-C3 | Hamilton Medical AG | 2017 | 2 |
| +1 | K180295 | Hamilton-G5 | Hamiton Medical AG | 2019 | — |
| +1 | K140939 | Hamilton-T1,Hamilton-C1 | Hamilton Medical AG | 2015 | 1 |
| +2 | K201658 | Hamilton-C6 | Hamilton Medical AG | 2020 | Class I |
| +2 | K193228 | Hamilton-G5 | Hamilton Medical AG | 2020 | — |
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 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 3 |
| 1999 | 6 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 1 |
| 2004 | 7 | 1 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 4 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
13 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 |
|---|---|---|---|
| * | K103803 | Hamilton-G5Summary page 1…11Oximeter (DQA) REGULATION NUMBER & 21 CFR 868.5895 (C6K) PRODUCT CODE 21 CFR 870.2700 (DQA) PREDICATE DEVICE: HAMILTON-GS (K103803 (PRIMARY) PREDICATE DEVICE: MAQUET Servo-i (K073179) (SECONDARY) For the Volume-Support mo… | 2011 |
| * | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Summary page 1…PRODUCT CODE 21 CFR 870.2700 (DQA) PREDICATE DEVICE: HAMILTON-GS (K103803 (PRIMARY) PREDICATE DEVICE: MAQUET Servo-i (K073179) (SECONDARY) For the Volume-Support mode MASIMO RAINBOW SET RADICAL… | 2008 |
| † | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | 2010 |
| † | K974292 | Nihon Kohden TL-101T, TL-120T and TL-121T SPO2 Probes and Accessories | 1998 |
| † | K011918 | Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series | 2001 |
| † | K032749 | Bedside Monitor, Model Opv-1500 | 2003 |
| † | K043517 | Transmitter, ZS-940PA Series | 2005 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (13 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. |
| Apr 22, 2014 | Class I | Z-0151-2016 | Device Design | Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and… |
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.
- K103803Hamilton-G5Hamilton Medical AG · 2011 · Direct predicate · ◆ 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 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 96 ancestors have a recall of any class; 8 have a Class I recall.
- Of its descendants, K161450 (Hamilton Medical AG, 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K103803.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for…
Read the full statement (129 words)
The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied.
The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. 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/K131774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131774: 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/K131774
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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