510(k) · Cleared
Recalled · Class II · 2017Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ion Beam Application S.A. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Aug 9, 2016 as substantially equivalent to K132919 (Ion Beam Applications S.A., 2014) and 1 other predicate after a 368-day review. Its family tree reaches back 6 generations to 1988. 4 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 9, 2016
- Review
- 368 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 6 generations to K872369 (1988). 14 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 5 generations backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- 4 generations backK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
- 3 generations backK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled
- 2 generations backK062891 Proton Therapy SystemIndiana University Cyclotron Facility · 2006
- 1 generation backK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · Recalled
- This deviceK152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus…Ion Beam Application S.A. · 2016
- Descendant · cites it directly · 2 of its ownK172848 MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK250986 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253406 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK163500 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus…Ion Beam Applications S.A. · 2017 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · cites it directly2descendants
- K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025 · 2 generations on1descendant
- K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026 · 3 generations on0descendants
- K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus…Ion Beam Applications S.A. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −5 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| −4 | K053641 | Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2006 | — |
| −3 | K060695 | Iba Proton Therapy System - Proteus 235 | Ion Beam Applications S.A. | 2006 | 2 |
| −2 | K062891 | Proton Therapy System | Indiana University Cyclotron Facility | 2006 | — |
| −1 | K120676 | S-250 Proton Beam Radiation Therapy System | Mevion Medical Systems | 2012 | 12 |
| 0 (this device) | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016 | — |
| +1 | K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017 | 5 |
| +2 | K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025 | — |
| +3 | K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026 | — |
| +1 | K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus… | Ion Beam Applications S.A. | 2017 | 11 |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K132919 | Gantry Beam LineSummary page 5…y System – Proteus 235 (PTS) with the addition of the IBA Compact Beam Production System is substantially equivalent to the previously cleared IBA Proton Therapy System (K132919) and to the S-250 Proton Beam Radiation Therapy system (K120676) from Mevion Medical Systems that includes a super conducting syn… | 2014 |
| * | K120676 | S-250 Proton Beam Radiation Therapy SystemSummary page 5…t Beam Production System is substantially equivalent to the previously cleared IBA Proton Therapy System (K132919) and to the S-250 Proton Beam Radiation Therapy system (K120676) from Mevion Medical Systems that includes a super conducting synchrocyclotron accelerator. The current PTS and its predicate dev… | 2012 |
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| Nov 1, 2017 | Class II | Z-0943-2018 | Device Design | The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. |
| Apr 10, 2017 | Class II | Z-2097-2017 | Software design | A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose. |
| Mar 21, 2017 | Class II | Z-1830-2017 | Software design | In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data. |
| Feb 9, 2017 | Class II | Z-2592-2017 | Device Design | It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating… |
| Dec 13, 2016 | Class II | Z-2684-2017 | Software design | Software issue |
| Sep 16, 2016 | Class II | Z-2139-2018 | Finished device change control | IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk. |
| Apr 11, 2016 | Class II | Z-2284-2018 | Software Manufacturing/Software Deployment | IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K172848 (Mevion Medical Systems, 2017) has gone furthest, with 2 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. 2016, 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 Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to
produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to
treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients
with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152224: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152224
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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