510(k) · Cleared
Recalled · Class II · 2021Modification to Iba Proton Therapy System-Proteus 235
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ion Beam Applications S.A. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Aug 6, 2010 as substantially equivalent to K983024 (Ion Beam Applications S.A., 2001) after a 66-day review. Its family tree reaches back 2 generations to 1988. 6 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 6, 2010
- Review
- 66 days
- Class
- Class II
- Product code
- LHN
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872369 (1988). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 1 generation backK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
- This deviceK101508 Modification to Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2010
- Descendant · cites it directly · 5 of its ownK132919 Gantry Beam LineIon Beam Applications S.A. · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK152224 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus…Ion Beam Application S.A. · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK172848 MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK250986 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK253406 S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132919Gantry Beam LineIon Beam Applications S.A. · 2014 · cites it directly5descendants
- K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 2016 · 2 generations on4descendants
- K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · 3 generations on2descendants
- K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2025 · 4 generations on1descendant
- K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −1 | K983024 | Proton Therapy System | Ion Beam Applications S.A. | 2001 | — |
| 0 (this device) | K101508 | Modification to Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | 2010 | — |
| +1 | K132919 | Gantry Beam Line | Ion Beam Applications S.A. | 2014 | 2 |
| +2 | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016 | 7 |
| +3 | K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017 | 5 |
| +4 | K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025 | — |
| +5 | K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K983024 | Proton Therapy SystemSummary page 2…rapy systems. (21 C.F.R. §892.5050) Predicate Device ' The PTS (proton therapy system) is substantially equivalent to the previously cleared |IBA proton therapy system (K983024). The current PTS and its predicate device have the same intended use and principles of operation, and are substantially equivale… | 2001 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132919 | Gantry Beam Line | 2014 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 26, 2021 | Class II | Z-2155-2021 | Labeling design | if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be… |
| May 16, 2018 | Class II | Z-2424-2018 | Software design | Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position. |
| Jan 26, 2018 | Class II | Z-1477-2018 | Under Investigation by firm | When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the… |
| Nov 17, 2017 | Class II | Z-0938-2018 | Device Design | There is a risk of misalignment of the patient when using treatment plans with multiple isocenters. |
| Oct 17, 2017 | Class II | Z-0930-2018 | Component design/selection | IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader |
| Mar 9, 2017 | Class II | Z-1695-2017 | Component design/selection | The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. |
The 5 latest of 6 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 22 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132919 (Ion Beam Applications S.A., 2014) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K983024.
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. 2010, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101508: Modification to Iba Proton Therapy System-Proteus 235.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101508
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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