510(k) · Cleared
Recalled · Class II · 2016Hamilton-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 26, 2007 as substantially equivalent to K061090 (Hamilton Medical AG, 2006) and 1 other predicate after a 277-day review. Its family tree reaches back 8 generations to 1991. 18 of the 57 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 2007
- Review
- 277 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K902859 (1991). 30 ancestors in all, the oldest K902506 (1991). 26 later devices descend from it, 3 citing it directly. 18 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK961687 EVITA 4Drager, Inc. · 1996
- 6 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 4 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 3 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 2 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 1 generation backK061090 Galileo Gold AsvHamilton Medical AG · 2006
- This deviceK070513 Hamilton-G5Hamilton Medical AG · 2007
- Descendant · cites it directly · 16 of its ownK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 14 of its ownK102775 Hamilton-C2Hamilton Medical AG · 2011
- Descendant · 3 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
- Descendant · 4 generations on · 11 of its ownK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
Showing 5 of 26 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
- K001646 Puritan-Bennett 840 Ventilator System with…3 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…3 generations back · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…4 generations back · 1998
Most influential descendants
Showing 5 of 26 · See all- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · cites it directly16descendants
- K102775Hamilton-C2Hamilton Medical AG · 2011 · 2 generations on14descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 3 generations on13descendants
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on11descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −6 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −4 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −3 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −2 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −1 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| 0 (this device) | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | — |
| +1 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| +2 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| +3 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| +4 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| +3 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2009 | 2 | 0 |
| 2011 | 3 | 2 |
| 2012 | 5 | 2 |
| 2014 | 1 | 1 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 3 | 2 |
| 2019 | 1 | 1 |
| 2020 | 2 | 2 |
| 2021 | 2 | 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.
18 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 |
|---|---|---|---|
| * | K061090 | Galileo Gold AsvSummary page 1…ntinuous, Facility Use (21 CFR 868.5895, Product Code: CBK) LEGALLY MARKETED HAMILTON GALILEO GoldAsV DEVICES TO WHICH 510(k) Number: K061090 EQUIVALENCE IS BEING CLAIMED: MAQUET Servo-i 510(k) Number: K041223… | 2006 |
| * | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407ESummary page 1…D HAMILTON GALILEO GoldAsV DEVICES TO WHICH 510(k) Number: K061090 EQUIVALENCE IS BEING CLAIMED: MAQUET Servo-i 510(k) Number: K041223 Page I of 3 HAMILTON… | 2004 |
What descends from it? (26)
See all 263 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (18 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
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
- 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
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
Nearest 12 of 18 shown.
Nearest 5 of 18; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 12 of the 30 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K081521 (Hamilton Medical AG, 2008) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K061090.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 adults, pediatrics, and optionally
infants.
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/K070513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070513: 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/K070513
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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