510(k) · Cleared
ClearedPT2 Varian Proton Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Oncology Systems · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Dec 27, 2010 as substantially equivalent to K082416 (Ion Beam Applications S.A., 2008) after a 231-day review. Its family tree reaches back 2 generations to 1988. 10 later devices descend from it.
- Decided
- Dec 27, 2010
- Review
- 231 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872369 (1988). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
- 1 generation backK082416 Iba Proton Therapy System- Proteus 235Ion Beam Applications S.A. · 2008 · Recalled
- This deviceK101294 PT2 Varian Proton Therapy SystemVarian Medical Systems, Oncology Systems · 2010
- Descendant · cites it directly · 5 of its ownK120676 S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · 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 · cites it directly · 3 of its ownK133191 Probeam Proton Therapy SystemVarian Medical Systems · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK221791 ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK172848 MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems · 2012 · cites it directly5descendants
- K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 2016 · 2 generations on4descendants
- K133191Probeam Proton Therapy SystemVarian Medical Systems · 2014 · cites it directly3descendants
- K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022 · 2 generations on2descendants
- K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017 · 2 generations on2descendants
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 | K082416 | Iba Proton Therapy System- Proteus 235 | Ion Beam Applications S.A. | 2008 | 3 |
| 0 (this device) | K101294 | PT2 Varian Proton Therapy System | Varian Medical Systems, Oncology Systems | 2010 | — |
| +1 | K120676 | S-250 Proton Beam Radiation Therapy System | Mevion Medical Systems | 2012 | 12 |
| +2 | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016 | 7 |
| +1 | K133191 | Probeam Proton Therapy System | Varian Medical Systems | 2014 | 1 |
| +2 | K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022 | — |
| +2 | K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082416 | Iba Proton Therapy System- Proteus 235Summary page 1…CFR 892.5050, Class Il Product Code: LHN Common/Usual Name: Proton Therapy System Predicate Devices; Proteus 235 Proton Therapy System from lon Beam Applications S.A. (K082416). Davice Description; PT2 Varian Proton Therapy System is a proton radiation therapy system which delivers therapeutic radiation… | 2008 |
What descends from it? (10)
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)
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 22 years and passes through 3 companies; a new generation was cleared every 20.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K120676 (Mevion Medical Systems, 2012) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K082416.
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?
PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of
lesions, tumors, and conditions anywhere in the body where radiation treatment is
indicated.
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/K101294 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101294: PT2 Varian Proton Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101294
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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