510(k) · Cleared
Recalled · Class II · 2022MEVION S250i Proton Beam Radiation Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mevion Medical Systems · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Dec 27, 2017 as substantially equivalent to K120676 (Mevion Medical Systems, 2012) and 1 other predicate after a 99-day review. Its family tree reaches back 7 generations to 1988. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 27, 2017
- Review
- 99 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 7 generations to K872369 (1988). 15 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 6 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 5 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 4 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 3 generations backK062891 Proton Therapy SystemIndiana University Cyclotron Facility · 2006
- 2 generations backK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · Recalled
- 1 generation backK152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus…Ion Beam Application S.A. · 2016 · Recalled
- This deviceK172848 MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017
- Descendant · cites it directly · 1 of its ownK250986 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253406 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −6 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −5 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −4 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −3 | K062891 | Proton Therapy System | Indiana University Cyclotron Facility | 2006 | — |
| −2 | K120676 | S-250 Proton Beam Radiation Therapy System | Mevion Medical Systems | 2012 | 12 |
| −1 | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016 | 7 |
| 0 (this device) | K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017 | — |
| +1 | K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025 | — |
| +2 | K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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.
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? (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 |
|---|---|---|---|
| * | K120676 | S-250 Proton Beam Radiation Therapy SystemSummary page 7…rgy modulation system (range shifter), and the adaptive aperture collimation (dynamic Micro-MLC) system. A Patient Positioning System, the same as in the cleared S-250 (K120676), includes a Treatment Couch and offers a 2D and 3D patient setup system… | 2012 |
| * | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Summary page 8…e not new or novel and raise no new issues of safety or efficacy. The Ion Beam Application’s (IBA’s) Proteus One (Proteus 235) is a substantially equivalent and cleared (K152224) device that offers a Beam Scanning modality. The Technical Characteristics of the new MEVION S250i Beam Scanning Modality are Su… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2022 | Class II | Z-0827-2022 | Component design/selection | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room. |
| Oct 19, 2020 | Class II | Z-0485-2021 | Device Design | Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur |
| May 15, 2020 | Class II | Z-2406-2020 | Software design | Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off |
| Oct 1, 2018 | Class II | Z-0705-2019 | Software Manufacturing/Software Deployment | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped |
| Jun 29, 2018 | Class II | Z-2746-2018 | Device Design | QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 7 of the 15 ancestors have a recall of any class.
- Of its descendants, K250986 (Mevion Medical Systems, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120676.
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. 2017, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The MEVION S250i is intended to deliver proton radiation therapy treatment to patients with localized tumors or other conditions susceptible to treatment by radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172848: MEVION S250i Proton Beam Radiation Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172848
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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