510(k) · Cleared
ClearedSumitomo Proton Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sumitomo Heavy Industries, Ltd. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Aug 17, 2016 as substantially equivalent to K130426 (Sumitomo Heavy Industries, Ltd., 2013) after a 167-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Aug 17, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K872369 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 3 generations backK992414 Proton Beam Therapy System (PBTS)Optivus Technology, Inc. · 2000
- 2 generations backK053280 ProbeatHitachi, Ltd., Power Systems Group · 2006
- 1 generation backK130426 Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. · 2013
- This deviceK160612 Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K872369 | Loma Linda Univ. Proton Beam Therapy System | Loma Linda University Medical Center | 1988 | — |
| −3 | K992414 | Proton Beam Therapy System (PBTS) | Optivus Technology, Inc. | 2000 | — |
| −2 | K053280 | Probeat | Hitachi, Ltd., Power Systems Group | 2006 | — |
| −1 | K130426 | Sumitomo Proton Therapy System | Sumitomo Heavy Industries, Ltd. | 2013 | — |
| 0 (this device) | K160612 | Sumitomo Proton Therapy System | Sumitomo Heavy Industries, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K130426 | Sumitomo Proton Therapy SystemSummary page 4…egulation: 21 CFR 892.5050 Product Code: LHN 3. PREDICATE DEVICE • Sumitomo Proton Therapy System, Sumitomo Heavy Industries, Ltd. (K130426) • IBA Proton Therapy System- Proteus 235, Ion Beam Applications, S.A. (K082416) 4. DEVICE DESCRIPTION The Sumitomo Pr… | 2013 |
| † | K082416 | Iba Proton Therapy System- Proteus 235 | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- None of the 6 ancestors has a recall.
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 Sumitomo Proton Therapy System is a medical device designed to produce and deliver a proton beam for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160612: Sumitomo Proton Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160612
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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