510(k) · Cleared
ClearedHamilton-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 May 4, 2020 as substantially equivalent to K180295 (Hamiton Medical AG, 2019) after a 164-day review. Its family tree reaches back 14 generations to 1991. 9 of the 100 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- May 4, 2020
- Review
- 164 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K902859 (1991). 98 ancestors in all, the oldest K791045 (1979). 1 later device descends from it, 1 citing it directly. 9 of the 100 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations between
- 3 generations backK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- 2 generations backK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- 1 generation backK180295 Hamilton-G5Hamiton Medical AG · 2019
- This deviceK193228 Hamilton-G5Hamilton Medical AG · 2020
- Descendant · cites it directly · 0 of its ownK231778 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC · 2024
Show all 14 generations
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 13 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 12 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 11 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 10 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 9 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 8 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 7 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 5 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 4 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 3 generations backK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- 2 generations backK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- 1 generation backK180295 Hamilton-G5Hamiton Medical AG · 2019
- This deviceK193228 Hamilton-G5Hamilton Medical AG · 2020
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −13 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −12 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −11 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −10 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −9 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −8 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −7 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −5 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −4 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −3 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
| −2 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | Class I |
| −1 | K180295 | Hamilton-G5 | Hamiton Medical AG | 2019 | — |
| 0 (this device) | K193228 | Hamilton-G5 | Hamilton Medical AG | 2020 | — |
| +1 | K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | 2024 | — |
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 |
|---|---|---|
| 2024 | 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.
9 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? (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 |
|---|---|---|---|
| * | K180295 | Hamilton-G5Summary page 4…and Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK (secondary: DQA) III. PREDICATE DEVICE HAMILTON-G5 (K180295) (primary predicate device) IV. REFERENCE DEVICES Hamilton Medical AG: HAMILTON-H900 (K152029, K163283) RESPIRO… | 2019 |
| † | K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010 | 2016 |
| † | K163283 | Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010 | 2017 |
| † | K102054 | V200 Ventilator | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | 2024 | 0 |
Has anything in its family been recalled? (9 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.
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 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 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 5 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 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 7 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 8 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 29 of the 98 ancestors have a recall of any class; 9 have a Class I recall.
- Of its descendants, K231778 (Nihon Kohden Orangemed, LLC, 2024) has gone furthest, with 0 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. 2020, 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-GS 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-GS ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-GS ventilator may be used for…
Read the full statement (129 words)
The HAMILTON-GS 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-GS ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician.
The HAMILTON-GS 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193228: Hamilton-G5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193228
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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