510(k) · Cleared
Recalled · Class II · 2020Mevatron, M 2 Class
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Laboratories, Inc. · IYE Accelerator, Linear, Medical
Cleared on Sep 19, 1988 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 39 later devices descend from it. It has been recalled 38 times.
- Decided
- Sep 19, 1988
- Review
- 75 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 38
- Predicates
- 0
39 later devices descend from it, 3 citing it directly.
- This deviceK882729 Mevatron, M 2 ClassSiemens Medical Laboratories, Inc. · 1988
- Descendant · cites it directly · 28 of its ownK982502 Genesis Imrt Linear AcceleratorSiemens Medical Solutions USA, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 27 of its ownK013673 HI-Art SystemTomo Therapy, Inc. · 2002
- Descendant · 3 generations on · 26 of its ownK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
- Descendant · 4 generations on · 25 of its ownK042739 HI-Art SystemTomotherapy Incorporated · 2004
- Descendant · 5 generations on · 24 of its ownK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
1998high 4 (2009) · low 0 (2000)2026
Most influential descendants
Showing 5 of 39 · See all- K982502Genesis Imrt Linear AcceleratorSiemens Medical Solutions USA, Inc. · 1998 · cites it directly28descendants
- K013673HI-Art SystemTomo Therapy, Inc. · 2002 · 2 generations on27descendants
- K033347Modification to: HI-Art SystemTomotherapy Incorporated · 2003 · 3 generations on26descendants
- K042739HI-Art SystemTomotherapy Incorporated · 2004 · 4 generations on25descendants
- K060912Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882729 | Mevatron, M 2 Class | Siemens Medical Laboratories, Inc. | 1988 | — |
| +1 | K982502 | Genesis Imrt Linear Accelerator | Siemens Medical Solutions USA, Inc. | 1998 | 4 |
| +2 | K013673 | HI-Art System | Tomo Therapy, Inc. | 2002 | — |
| +3 | K033347 | Modification to: HI-Art System | Tomotherapy Incorporated | 2003 | — |
| +4 | K042739 | HI-Art System | Tomotherapy Incorporated | 2004 | — |
| +5 | K060912 | Modification to: HI-Art System | Tomotherapy Incorporated | 2006 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (39)
See all 393 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2020 | Class II | Z-1678-2020 | Use error | Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| Feb 18, 2020 | Class II | Z-1679-2020 | Use error | Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy. |
| Jan 25, 2017 | Class II | Z-1436-2017 | Under Investigation by firm | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any… |
| Dec 1, 2011 | Not classified | Z-0787-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0788-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0796-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0792-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0793-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0783-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0784-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0786-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0789-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0790-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0794-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0798-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0780-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0781-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0785-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0791-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0795-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Dec 1, 2011 | Not classified | Z-0797-2012 | Nonconforming Material/Component | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Jan 11, 2008 | Not classified | Z-1402-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Jan 11, 2008 | Not classified | Z-1401-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Aug 7, 2007 | Not classified | Z-0683-2008 | Device Design | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial… |
| Aug 7, 2007 | Not classified | Z-0678-2008 | Device Design | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial… |
| Aug 7, 2007 | Not classified | Z-0679-2008 | Device Design | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial… |
| Aug 7, 2007 | Not classified | Z-0682-2008 | Device Design | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial… |
| Aug 7, 2007 | Not classified | Z-0684-2008 | Device Design | Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial… |
| Jul 27, 2007 | Not classified | Z-0852-2008 | Component design/selection | Door Hinge failures; loose or falling off (Stationary Structure Doors) |
| Mar 22, 2007 | Not classified | Z-0156-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0162-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0163-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0155-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0159-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0161-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0157-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0160-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
| Mar 22, 2007 | Not classified | Z-0158-2008 | Software design | Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of… |
The 5 latest of 38 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982502 (Siemens Medical Solutions USA, Inc., 1998) has gone furthest, with 28 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2007high 28 (2012) · low 9 (2024)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
2007high 239 (2024) · low 44 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
2007high 78 (2007) · low 1 (2024)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
2007high 280 (2011) · low 66 (2022)2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
https://510kreport.com/device/K882729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882729: Mevatron, M 2 Class.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882729
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026