510(k) · Cleared
ClearedSiemens Mevatron ME
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Laboratories, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Sep 19, 1985 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Sep 19, 1985
- Review
- 72 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly.
- This deviceK852907 Siemens Mevatron MESiemens Medical Laboratories, Inc. · 1985
- Descendant · cites it directly · 25 of its ownK981112 MobetronIntraop Medical, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 20 of its ownK992577 Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999
- Descendant · 3 generations on · 9 of its ownK051055 Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · Recalled
- Descendant · 3 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K981112MobetronIntraop Medical, Inc. · 1998 · cites it directly25descendants
- K992577Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999 · 2 generations on20descendants
- K051055Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · 3 generations on9descendants
- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 3 generations on8descendants
- K050843Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K852907 | Siemens Mevatron ME | Siemens Medical Laboratories, Inc. | 1985 | — |
| +1 | K981112 | Mobetron | Intraop Medical, Inc. | 1998 | 1 |
| +2 | K992577 | Photon Radiosurgery System (PRS) | Photoelectron Corporation | 1999 | — |
| +3 | K051055 | Intrabeam System | Carl Zeiss Surgical GmbH | 2005 | 2 |
| +3 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| +3 | K050843 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 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? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981112 | Mobetron | 1998 | 25 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981112 (Intraop Medical, Inc., 1998) has gone furthest, with 25 descendants of its own.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
https://510kreport.com/device/K852907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K852907: Siemens Mevatron ME.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K852907
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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