510(k) · Cleared
Recalled · 2006Raphael
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 22, 2003 as substantially equivalent to K001686 (Hamilton Medical, Inc., 2000) and 3 other predicates after a 436-day review. Its family tree reaches back 4 generations to 1991. 21 of the 66 devices in its family, counting itself, have a Class I recall. 54 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 22, 2003
- Review
- 436 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 4 generations to K902859 (1991). 11 ancestors in all, the oldest K902506 (1991). 54 later devices descend from it, 1 citing it directly. 21 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 3 generations backK961687 EVITA 4Drager, Inc. · 1996
- 2 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 1 generation backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- This deviceK022679 RaphaelHamilton Medical AG · 2003
- Descendant · cites it directly · 53 of its ownK040574 Galileo GoldHamilton Medical, Inc. · 2004
- Descendant · 2 generations on · 51 of its ownK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- Descendant · 2 generations on · 36 of its ownK061090 Galileo Gold AsvHamilton Medical AG · 2006
- Descendant · 3 generations on · 26 of its ownK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- Descendant · 3 generations on · 23 of its ownK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 54 · See all- K040574Galileo GoldHamilton Medical, Inc. · 2004 · cites it directly53descendants
- K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · 2 generations on51descendants
- K061090Galileo Gold AsvHamilton Medical AG · 2006 · 2 generations on36descendants
- K070513Hamilton-G5Hamilton Medical AG · 2007 · 3 generations on26descendants
- K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa · 2008 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −3 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −2 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −1 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| 0 (this device) | K022679 | Raphael | Hamilton Medical AG | 2003 | — |
| +1 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| +2 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| +2 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| +3 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| +3 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor… | Drager Medical AG & Co. Kgaa | 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 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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.
21 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? (4)
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 |
|---|---|---|---|
| * | K001686 | Galileo Ventilator Our reading of the summary gave K001685, FDA’s number for PSN Hemodialyzer, Model PSN 130, 150, 170, 210 (Baxter Healthcare Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Galileo”. | 2000 |
| * | K970165 | Evita 2 DuraSummary page 1…MEDICAL IS CLAlMMG SUBSTANTIAL EQUWAL-ENCE Galilea 51O(k)#: K 001685 -Manufactured by Hamilton Medic& AG Drgger Evita 2 Dura 5 1OR)& K 970 165 -Manuf&Ured by D&gw Medizintedwik Siemens Servo4 5 IO@& K 010925 -Mmufictu& by S i m s - E l e m i i… | 1997 |
| * | K010925 | Servoi Ventilator System, Model 64 87 800 E407ESummary page 1…85 -Manufactured by Hamilton Medic& AG Drgger Evita 2 Dura 5 1OR)& K 970 165 -Manuf&Ured by D&gw Medizintedwik Siemens Servo4 5 IO@& K 010925 -Mmufictu& by S i m s - E l e m i i A3 Puritan Sennett 840 51O(k)#: IC984535 -Manufactured by Nellm Prurita… | 2001 |
| * | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel OptionSummary page 1…-Manuf&Ured by D&gw Medizintedwik Siemens Servo4 5 IO@& K 010925 -Mmufictu& by S i m s - E l e m i i A3 Puritan Sennett 840 51O(k)#: IC984535 -Manufactured by Nellm Pruritan Bennett DEVICE DESGRIPTION The W f I M Lis an microprocessorcontrolled &tical care venti… | 1998 |
What descends from it? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040574 | Galileo Gold | 2004 | 53 |
Has anything in its family been recalled? (21 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.
- 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 · 3 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 · 3 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 · 3 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 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
Nearest 12 of 21 shown.
Nearest 5 of 21; all are on the web page.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K040574 (Hamilton Medical, Inc., 2004) has gone furthest, with 53 descendants of its own.
- 3 other devices also cite its predicate K001686.
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 ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg. The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator 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/K022679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022679: Raphael.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022679
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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