510(k) · Cleared
Recalled · Class II · 2016Hamilton-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 Nov 20, 2013 as substantially equivalent to K111473 (Impact Instrumentation, Inc., 2012) and 1 other predicate after a 467-day review. Its family tree reaches back 13 generations to 1991. 6 of the 69 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 20, 2013
- Review
- 467 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 13 generations to K902859 (1991). 67 ancestors in all, the oldest K861272 (1986). 1 later device descends from it, 1 citing it directly. 6 of the 69 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations between
- 3 generations backK091238 Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · Recalled
- 2 generations backK103318 Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · Recalled
- 1 generation backK111473 Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · Recalled (Class I)
- This deviceK122438 Hamilton-MR1Hamilton Medical AG · 2013
- Descendant · cites it directly · 0 of its ownK153046 Hamilton-MR1Hamilton Medical AG · 2016 · Recalled (Class I)
Show all 13 generations
- Root · 13 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 12 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 11 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 10 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 9 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 8 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 7 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 6 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 5 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK071526 Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 2008 · Recalled
- 3 generations backK091238 Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · Recalled
- 2 generations backK103318 Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · Recalled
- 1 generation backK111473 Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · Recalled (Class I)
- This deviceK122438 Hamilton-MR1Hamilton Medical AG · 2013
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K153046Hamilton-MR1Hamilton Medical AG · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −12 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −11 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −10 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −9 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −8 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −7 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −6 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −5 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMV | Impact Instrumentation, Inc. | 2008 | 1 |
| −3 | K091238 | Uni-Vent-731 Series Ventilators, Model 731EMV+ | Impact Instrumentation, Inc. | 2009 | 1 |
| −2 | K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator | Impact Instrumentation, Inc. | 2011 | 2 |
| −1 | K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator | Impact Instrumentation, Inc. | 2012 | Class I |
| 0 (this device) | K122438 | Hamilton-MR1 | Hamilton Medical AG | 2013 | — |
| +1 | K153046 | Hamilton-MR1 | Hamilton Medical AG | 2016 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 2 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 1 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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.
6 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 |
|---|---|---|---|
| * | K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator | 2012 |
| * | K050055 | GE Datex-Ohmeda Aestiva/5 Mri Anesthesia SystemSummary page 1…51 0(k) Number: KI 11473 AESTIVAI5 MRI anesthesia system 510(k) Number: K050055 PagelIof 7 K122438 DEVICE DESCRIPTION… | 2005 |
| * | — | Hamilton-C1 Named without a submission number |
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 |
|---|---|---|---|
| K153046 | Hamilton-MR1 Class I | 2016 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2016 | Class II | Z-0666-2017 | Device Design | Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for 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.
- K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 6 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 21 of the 67 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K153046 (Hamilton Medical AG, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111473.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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.
intended areas of use:
* In the MRI department
* In the Intensive care ward 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 T and 3.0 Tesla static magnetic field scanners.
The HAMILTON-MR1 ventilator is a restricted 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 as stated in the FDA summary.
https://510kreport.com/device/K122438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122438: 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/K122438
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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