510(k) · Cleared
Recalled · Class I · 2023Hamilton-MR1
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 Sep 6, 2016 as substantially equivalent to K122438 (Hamilton Medical AG, 2013) and 1 other predicate after a 323-day review. Its family tree reaches back 15 generations to 1991. 16 of the 139 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Sep 6, 2016
- Review
- 323 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 15 generations to K902859 (1991). 138 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet. 16 of the 139 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations between
- 3 generations backK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- 2 generations backK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- 1 generation backK140939 Hamilton-T1,Hamilton-C1Hamilton Medical AG · 2015 · Recalled
- This deviceK153046 Hamilton-MR1Hamilton Medical AG · 2016
Show all 15 generations
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 14 generations backK961687 EVITA 4Drager, Inc. · 1996
- 13 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 12 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 11 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 10 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 9 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 8 generations backK061090 Galileo Gold AsvHamilton Medical AG · 2006
- 7 generations backK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- 6 generations backK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- 5 generations backK102775 Hamilton-C2Hamilton Medical AG · 2011
- 4 generations backK112006 Hamilton-TC1Hamilton Medical AG · 2012
- 3 generations backK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- 2 generations backK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- 1 generation backK140939 Hamilton-T1,Hamilton-C1Hamilton Medical AG · 2015 · Recalled
- This deviceK153046 Hamilton-MR1Hamilton Medical AG · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −14 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −13 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −12 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −11 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −10 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −9 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −8 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| −7 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| −6 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| −5 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| −4 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| −3 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| −2 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| −1 | K140939 | Hamilton-T1,Hamilton-C1 | Hamilton Medical AG | 2015 | 1 |
| 0 (this device) | K153046 | Hamilton-MR1 | Hamilton Medical AG | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 10 | 1 |
| 1999 | 9 | 0 |
| 2000 | 5 | 1 |
| 2001 | 6 | 0 |
| 2002 | 5 | 1 |
| 2003 | 6 | 1 |
| 2004 | 12 | 1 |
| 2005 | 5 | 0 |
| 2006 | 7 | 1 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 1 |
| 2011 | 2 | 1 |
| 2012 | 2 | 1 |
| 2013 | 2 | 1 |
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.
16 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 |
|---|---|---|---|
| * | K122438 | Hamilton-MR1Summary page 4…ulation Number and Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK III. PREDICATE DEVICES HAMILTON-MR1 (K122438) HAMILTON-C1/T1 (K140939) IV. DEVICE DESCRIPTION The HAMILTON-MR1 is an MR-Conditional ventilator which increas… | 2013 |
| * | K140939 | Hamilton-T1,Hamilton-C1Summary page 4…tor, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK III. PREDICATE DEVICES HAMILTON-MR1 (K122438) HAMILTON-C1/T1 (K140939) IV. DEVICE DESCRIPTION The HAMILTON-MR1 is an MR-Conditional ventilator which increases the availability of ap… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (16 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2023 | Class I | Z-2528-2023 | Nonconforming Material/Component | Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation. |
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.
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations back · ◆ in the 2013 ancestors bar of FIG. 12 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 13 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
Nearest 12 of 15 shown.
Nearest 5 of 15; all are on the web page.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 47 of the 138 ancestors have a recall of any class; 15 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. 2016, 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 HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Intended areas of use: • In the MRI department • In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room • During transfer of ventilated patients within the hospital The HAMILTON-MR1 ventilator is classified as MR Conditional with the use…
Read the full statement (109 words)
The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
• In the MRI department
• In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
• During transfer of ventilated patients within the hospital
The HAMILTON-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners.
The HAMILTON-MR1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153046: Hamilton-MR1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153046
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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