510(k) · Cleared
ClearedProBeam 360° Proton Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Dec 1, 2022 as substantially equivalent to K133191 (Varian Medical Systems, 2014) and 1 other predicate after a 163-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 1, 2022
- Review
- 163 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K963624 (1996). 12 ancestors in all, the oldest K872369 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 4 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 3 generations backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- 2 generations backK042720 ON-Board Imager DeviceVarian Medical Systems · 2004 · Recalled
- 1 generation backK133191 Probeam Proton Therapy SystemVarian Medical Systems · 2014 · Recalled
- This deviceK221791 ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK231863 ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252815 ProBeam 360 Proton Therapy System v3.0Varian 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 |
|---|---|---|---|---|---|
| −5 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −4 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −3 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| −2 | K042720 | ON-Board Imager Device | Varian Medical Systems | 2004 | 5 |
| −1 | K133191 | Probeam Proton Therapy System | Varian Medical Systems | 2014 | 1 |
| 0 (this device) | K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022 | — |
| +1 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023 | — |
| +1 | K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K133191 | Probeam Proton Therapy SystemSummary page 4…ation Therapy, Charged-Particle, Medical Regulation Number: §892.5050 Product Code: LHN III. Predicate Device ProBeam Proton Therapy System v2.0 (K133191) IV. Device Description The ProBeam 360° Proton Therapy System is a device that generates ionizing radiation (p… | 2014 |
| * | K160518 | LEONI ORION SystemSummary page 6…sRobotic Treatment Table Leoni Orion 6-AxisRobotic Treatment Substantially equivalent (K122413) Table (K160518) New patient positioni… | 2016 |
| † | K123291 | Truebeam | 2012 |
What descends from it? (2)
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 26 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 9 of the 12 ancestors have a recall of any class.
- Of its descendants, K231863 (Varian Medical Systems, Inc., 2023) has gone furthest, with 1 descendant 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. 2022, 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 ProBeam 360° 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 as stated in the FDA summary.
https://510kreport.com/device/K221791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221791: ProBeam 360° Proton Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221791
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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