510(k) · Cleared
Recalled · Class I · 2019Modification to Hamilton-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 Sep 25, 2008 as substantially equivalent to K070513 (Hamilton Medical AG, 2007) and 5 other predicates after a 118-day review. Its family tree reaches back 9 generations to 1991. 13 of the 71 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Sep 25, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2 (1 Class I)
- Predicates
- 6
Its longest line of descent runs back 9 generations to K902859 (1991). 54 ancestors in all, the oldest K833982 (1984). 16 later devices descend from it, 2 citing it directly. 13 of the 71 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK061090 Galileo Gold AsvHamilton Medical AG · 2006
- 1 generation backK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- This deviceK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008
- Descendant · cites it directly · 14 of its ownK102775 Hamilton-C2Hamilton Medical AG · 2011
- Descendant · 2 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
- Descendant · 3 generations on · 11 of its ownK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK123637 Hamilton-C3Hamilton Medical AG · 2012
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK961687 EVITA 4Drager, Inc. · 1996
- 7 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 6 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 4 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK061090 Galileo Gold AsvHamilton Medical AG · 2006
- 1 generation backK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- This deviceK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K041223 Modification to Servo-I Ventilator System, Model…direct predicate · 2004
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…2 generations back · 1998
- K001646 Puritan-Bennett 840 Ventilator System with…3 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…3 generations back · 1998
Most influential descendants
Showing 5 of 16 · See all- K102775Hamilton-C2Hamilton Medical AG · 2011 · cites it directly14descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 2 generations on13descendants
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 3 generations on11descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on8descendants
- K123637Hamilton-C3Hamilton Medical AG · 2012 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −7 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −6 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −4 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −3 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −2 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| −1 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| 0 (this device) | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | — |
| +1 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| +2 | 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 |
| +3 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 1 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 1 |
| 2004 | 5 | 1 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 2 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 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? (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 |
|---|---|---|---|
| * | K070513 | Hamilton-G5Summary page 1…entilator, Continuous, Facility Use (21 CFR 868.5895, Product Code: CB3K) HAMILTON-G5 510(k) Number: K070513 MAQUET Servo-i LEGALLY MARKETED 510(k) Number: K041223 DEVICES TO WHICH Viasys AVEA ventilator… | 2007 |
| * | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407ESummary page 1…Code: CB3K) HAMILTON-G5 510(k) Number: K070513 MAQUET Servo-i LEGALLY MARKETED 510(k) Number: K041223 DEVICES TO WHICH Viasys AVEA ventilator EQUIVALENCE IS 510(k) Number: K062093 BEING CLAIM ED: Datex-Ohmeda E… | 2004 |
| * | K062093 | Avea VentilatorSummary page 1…3 MAQUET Servo-i LEGALLY MARKETED 510(k) Number: K041223 DEVICES TO WHICH Viasys AVEA ventilator EQUIVALENCE IS 510(k) Number: K062093 BEING CLAIM ED: Datex-Ohmeda Engstromn Carestation 510(k) Number: K062710 Dr… | 2006 |
| * | K062710 | GE Datex-Ohmeda Engstrom CarestationSummary page 1…Viasys AVEA ventilator EQUIVALENCE IS 510(k) Number: K062093 BEING CLAIM ED: Datex-Ohmeda Engstromn Carestation 510(k) Number: K062710 Drager EvitaXL with NeoFlow Option 510(k) Numbers: K051263, K983219… | 2006 |
| * | K051263 | Evitaxl with Option SmartcareSummary page 1…meda Engstromn Carestation 510(k) Number: K062710 Drager EvitaXL with NeoFlow Option 510(k) Numbers: K051263, K983219 Page 1 of 3… | 2005 |
| * | K983219 | Neoflow Option Model Numbers 8413563, 8411900Summary page 1…tromn Carestation 510(k) Number: K062710 Drager EvitaXL with NeoFlow Option 510(k) Numbers: K051263, K983219 Page 1 of 3 HAMILTON… | 1998 |
What descends from it? (16)
See all 162 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… |
| Feb 16, 2011 | Not classified | Z-1928-2011 | Software design | The adaptive volume/pressure regulation can be automatically and permanently reduced to PEEP + 3 mbar when a closed suctioning maneuver is performed on the patient and may be undetected by the operator. |
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 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 5 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 17 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 54 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K102775 (Hamilton Medical AG, 2011) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K070513.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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/K081521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081521: Modification to 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/K081521
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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