510(k) · Cleared
ClearedRaphael Color Asv Ventilator
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 Oct 18, 2007 as substantially equivalent to K052863 (Hamilton Medical AG, 2006) and 1 other predicate after a 171-day review. Its family tree reaches back 8 generations to 1991. 3 of the 31 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 18, 2007
- Review
- 171 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K902859 (1991). 30 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet. 3 of the 31 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 deviceK071194 Raphael Color Asv VentilatorHamilton Medical AG · 2007
Class I recalls in this family
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) | K071194 | Raphael Color Asv Ventilator | Hamilton Medical AG | 2007 | — |
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 | 3 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2006 | 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.
3 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 |
|---|---|---|---|
| * | K052863 | Raphael ColorSummary page 1…RAPHAEL Color~sv is a software RESUBISON:FRTIS50K modified version of the legally marketed SUBMISSION: ~~~device RAPHAEL Color (K052863) HAMILTON RAPHAEL Color LEGALLY MARKETED DEVICES 510(k) Number: K052863 TO WHICH… | 2006 |
| * | K061090 | Galileo Gold AsvSummary page 1…2863 TO WHICH EQUIVALENCE IS ______________ BEING CLAIMED: HAMILTON GALILEO GoldASV 510(k) Number: K061090 Page I of 3 HA… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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 · 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
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
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 RAPHAEL ColorAsv ventilator is a continuous ventilator designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL ColorAs v ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color Asv is intended for use in a hospital or hospital-type facility, including use at a patient bedside or for intra-facility transport, provided compressed gas is supplied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071194: Raphael Color Asv Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071194
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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