510(k) · Cleared
Recalled · Class II · 2017Mevatron KD-2
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 Oct 29, 1986 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 16 times.
- Decided
- Oct 29, 1986
- Review
- 131 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 16
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK862339 Mevatron KD-2Siemens Medical Laboratories, Inc. · 1986
- Descendant · cites it directly · 16 of its ownK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 13 of its ownK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 11 of its ownK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · cites it directly16descendants
- K060226Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on13descendants
- K072485Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · 3 generations on11descendants
- K082775Prescision OptionSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on9descendants
- K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862339 | Mevatron KD-2 | Siemens Medical Laboratories, Inc. | 1986 | — |
| +1 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| +2 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| +3 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| +3 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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? (18)
See all 182 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 |
|---|---|---|---|---|
| Jan 25, 2017 | Class II | Z-1437-2017 | 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… |
| Nov 4, 2010 | Not classified | Z-2636-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Nov 4, 2010 | Not classified | Z-2638-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Nov 4, 2010 | Not classified | Z-2637-2011 | Other | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Jan 11, 2008 | Not classified | Z-1395-2008 | Software design | Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact. |
| Dec 10, 2007 | Not classified | Z-1758-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1755-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1753-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1756-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1757-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Dec 10, 2007 | Not classified | Z-1754-2008 | Device Design | Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. |
| Aug 7, 2007 | Not classified | Z-0680-2008 | 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-0677-2008 | 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-0681-2008 | 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-0685-2008 | 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-0851-2008 | Component design/selection | Door Hinge failures; loose or falling off (Stationary Structure Doors) |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031764 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 16 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
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 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/K862339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K862339: Mevatron KD-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862339
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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