510(k) · Cleared
ClearedGalileo Gold Asv
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 Jul 17, 2006 as substantially equivalent to K040574 (Hamilton Medical, Inc., 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 7 generations to 1991. 20 of the 64 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Jul 17, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K902859 (1991). 27 ancestors in all, the oldest K902506 (1991). 36 later devices descend from it, 4 citing it directly. 20 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK961687 EVITA 4Drager, Inc. · 1996
- 5 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 4 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 3 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 2 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 1 generation backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- This deviceK061090 Galileo Gold AsvHamilton Medical AG · 2006
- Descendant · cites it directly · 26 of its ownK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- Descendant · cites it directly · 21 of its ownK080181 Modification to Galileo GoldHamilton Medical AG · 2008
- Descendant · 2 generations on · 16 of its ownK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 14 of its ownK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 14 of its ownK102775 Hamilton-C2Hamilton Medical AG · 2011
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K001646 Puritan-Bennett 840 Ventilator System with…2 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…2 generations back · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…3 generations back · 1998
- K111116 Engstrom Carestation, Engstrom Pro, Models…2 generations on · 2011
Most influential descendants
Showing 5 of 36 · See all- K070513Hamilton-G5Hamilton Medical AG · 2007 · cites it directly26descendants
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · cites it directly21descendants
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on16descendants
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on14descendants
- K102775Hamilton-C2Hamilton Medical AG · 2011 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −5 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −4 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −3 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −2 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −1 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| 0 (this device) | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| +1 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| +1 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
| +2 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| +2 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
| +2 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 2 | 1 |
| 2009 | 2 | 0 |
| 2011 | 4 | 3 |
| 2012 | 5 | 2 |
| 2013 | 2 | 2 |
| 2014 | 1 | 1 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 3 | 2 |
| 2019 | 2 | 1 |
| 2020 | 3 | 2 |
| 2021 | 2 | 1 |
| 2024 | 2 | 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.
20 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 |
|---|---|---|---|
| * | K040574 | Galileo GoldSummary page 1…The GALILEO GoldASV is a software modified version of the legally marketed device GALILEO Gold (K040574) HAMILTON GALILEO Gold LEGALLY MARKETED DEVICES 510(k) Number: K040574 TO WHICH… | 2004 |
| * | K051263 | Evitaxl with Option SmartcareSummary page 1…(k) Number: K040574 TO WHICH EQUIVALENCE IS BEING CLAIMED: Driger EvitaXL with option SmartCare 510(k) Number: K051263 Page 1 of 3 H… | 2005 |
What descends from it? (36)
See all 364 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (20 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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 2 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 · 3 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 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 12 of 20 shown.
Nearest 5 of 20; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 27 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K070513 (Hamilton Medical AG, 2007) has gone furthest, with 26 descendants of its own.
- 2 other devices also cite its predicate K040574.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GALILEO GoldAsv ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and 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/K061090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061090: Galileo Gold Asv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061090
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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