510(k) · Cleared
ClearedGalileo Gold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Medical, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 27, 2004 as substantially equivalent to K022679 (Hamilton Medical AG, 2003) and 8 other predicates after a 237-day review. Its family tree reaches back 5 generations to 1991. 22 of the 77 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it.
- Decided
- Oct 27, 2004
- Review
- 237 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 5 generations to K902859 (1991). 23 ancestors in all, the oldest K902506 (1991). 53 later devices descend from it, 3 citing it directly. 22 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 4 generations backK961687 EVITA 4Drager, Inc. · 1996
- 3 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 2 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 1 generation backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- This deviceK040574 Galileo GoldHamilton Medical, Inc. · 2004
- Descendant · cites it directly · 51 of its ownK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- Descendant · cites it directly · 36 of its ownK061090 Galileo Gold AsvHamilton Medical AG · 2006
- Descendant · 2 generations on · 26 of its ownK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- Descendant · 2 generations on · 23 of its ownK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
- Descendant · 2 generations on · 21 of its ownK080181 Modification to Galileo GoldHamilton Medical AG · 2008
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 53 · See all- K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · cites it directly51descendants
- K061090Galileo Gold AsvHamilton Medical AG · 2006 · cites it directly36descendants
- K070513Hamilton-G5Hamilton Medical AG · 2007 · 2 generations on26descendants
- K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa · 2008 · 2 generations on23descendants
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −4 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −3 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −2 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −1 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| 0 (this device) | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| +1 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| +1 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| +2 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| +2 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor… | Drager Medical AG & Co. Kgaa | 2008 | — |
| +2 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
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 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 1 |
| 2007 | 3 | 0 |
| 2008 | 3 | 1 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 5 | 3 |
| 2012 | 6 | 2 |
| 2013 | 2 | 2 |
| 2014 | 1 | 1 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 3 | 2 |
| 2019 | 3 | 1 |
| 2020 | 3 | 2 |
| 2021 | 2 | 1 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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.
22 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? (9)
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 |
|---|---|---|---|
| * | K022679 | RaphaelSummary page 4…___ _______Bennett The 510(K) number To be assigned K970460, K984535, I(022679 - K993071,K1(01646,… | 2003 |
| * | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel OptionSummary page 2…Facility Use per 21 CFR 868.5895 Puritan Bennett 840 Nellcor Puritan-Bennett K984535, K001646 Ventilator, Continuous, F… | 1998 |
| * | K001646 | Puritan-Bennett 840 Ventilator System with Neomode OptionSummary page 2…Use per 21 CFR 868.5895 Puritan Bennett 840 Nellcor Puritan-Bennett K984535, K001646 Ventilator, Continuous, Facility U… | 2000 |
| * | K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474Summary page 2…21 CFR 868.5895 NIV mode Evita 4 Draeger K010093 Ventilator, Continuous, Medizintechnik AG Facili… | 2001 |
| * | K980642 | EVITA 4 (8411900)Summary page 2…Use per 21 CFR 868.5895 Evita 4 Draeger K980642 Ventilator, Continuous, Medizintechnik AG Facilit… | 1998 |
| * | K992608 | Atc Option for Evita 2 Dura and Evita 4Summary page 2…CFR 868.5895 TRC feature Evita 4 Draeger K992608 Ventilator, Continuous, Medizintechnik AG Facilit… | 1999 |
| * | K970839 | Servo Ventilator 300ASummary page 2…Use per 21 CFR 868.5895 Siemens Servo 300A Siemens-Elema AB K970839 Ventilator, Continuous, Facilit… | 1997 |
| * | K010925 | Servoi Ventilator System, Model 64 87 800 E407ESummary page 2…CFR 868.5895 MMV* mode Siemens Servo' Siemens-Elema AB K010925, K022132 Ventilator, Continuous, Facilit… | 2001 |
| * | K022132 | Servo Ventilator System, Model 64 87 800 E407ESummary page 2…CFR 868.5895 MMV* mode Siemens Servo' Siemens-Elema AB K010925, K022132 Ventilator, Continuous, Facility Use per… | 2002 |
What descends from it? (53)
See all 533 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (22 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 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Direct predicate · ◆ on the line of descent in 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
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 22 shown.
Nearest 5 of 22; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 23 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K051263 (Drager Medical AG & Co. Kgaa, 2005) has gone furthest, with 51 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.
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 Gold 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 or 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/K040574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040574: Galileo Gold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040574
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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