510(k) · Cleared
Recalled · 2006Raphael Color
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 Jan 6, 2006 as substantially equivalent to K982910 (Hamilton Medical, Inc., 1999) and 2 other predicates after an 87-day review. Its family tree reaches back 6 generations to 1991. 3 of the 27 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jan 6, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 6 generations to K902859 (1991). 25 ancestors in all, the oldest K902506 (1991). 1 later device descends from it, 1 citing it directly. 3 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK961687 EVITA 4Drager, Inc. · 1996
- 4 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 3 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 2 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 1 generation backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- This deviceK052863 Raphael ColorHamilton Medical AG · 2006
- Descendant · cites it directly · 0 of its ownK071194 Raphael Color Asv VentilatorHamilton Medical AG · 2007
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K071194Raphael Color Asv VentilatorHamilton Medical AG · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −4 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −3 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −2 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −1 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| 0 (this device) | K052863 | Raphael Color | Hamilton Medical AG | 2006 | — |
| +1 | 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 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (3)
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 |
|---|---|---|---|
| * | K982910 | Hamilton Medical GalileoventilatorSummary page 1…being claimed Predicate Device Manufacturer 510(k) number(s) Classification NIV mode and TRC feature GALILEO Gold HAMILTON MEDICAL K982910, K001686, Ventilator, Continuous, AG K040574 Faci… | 1999 |
| * | K001686 | Galileo VentilatorSummary page 1…imed Predicate Device Manufacturer 510(k) number(s) Classification NIV mode and TRC feature GALILEO Gold HAMILTON MEDICAL K982910, K001686, Ventilator, Continuous, AG K040574 Facility Use… | 2000 |
| * | K040574 | Galileo GoldSummary page 1…mode and TRC feature GALILEO Gold HAMILTON MEDICAL K982910, K001686, Ventilator, Continuous, AG K040574 Facility Use per 21 CFR 868.6895… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071194 | Raphael Color Asv Ventilator | 2007 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2006 | Not classified | Z-1250-06 | Other | ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system. |
| May 24, 2006 | Not classified | Z-1249-06 | Other | ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system. |
| May 24, 2006 | Not classified | Z-1251-06 | Other | ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system. |
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
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 25 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K071194 (Hamilton Medical AG, 2007) has gone furthest, with 0 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 RAPHAEL Color ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg. The RAPHAEL Color ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color 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/K052863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052863: Raphael Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052863
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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