510(k) · Cleared
ClearedProton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proton Systems · IYE Accelerator, Linear, Medical
Cleared on Oct 23, 2012 as substantially equivalent to K071077 (.Decimal, Inc., 2007) and 1 other predicate after a 140-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 23, 2012
- Review
- 140 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000137 (2000). 9 ancestors in all, the oldest K880047 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
- 3 generations backK021987 Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
- 2 generations backK040804 .Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004
- 1 generation backK071077 .Decimal Aperture.Decimal, Inc. · 2007
- This deviceK121657 Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion…Proton Systems · 2012
- Descendant · cites it directly · 0 of its ownK132236 .Decimal Proton Aperture.Decimal, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK131150 Cura CompensatorCura Medical Technologies, LLC · 2013
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 |
|---|---|---|---|---|---|
| −4 | K000137 | Enhanced Compensating Filter | Computerized Medical Systems, Inc. | 2000 | — |
| −3 | K021987 | Parcomplast Compensating Filter for Radiation Therapy | S&S Par Scientific | 2002 | — |
| −2 | K040804 | .Decimal Tissue Compensator/Intensity Modulator | Southeastern Radiation Products, Inc. | 2004 | — |
| −1 | K071077 | .Decimal Aperture | .Decimal, Inc. | 2007 | — |
| 0 (this device) | K121657 | Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy… | Proton Systems | 2012 | — |
| +1 | K132236 | .Decimal Proton Aperture | .Decimal, Inc. | 2013 | — |
| +1 | K131150 | Cura Compensator | Cura Medical Technologies, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K071077 | .Decimal ApertureSummary page 2…=== Proton Systems Traditional 510(k) Premarket Submission Radiation Therapy Beam-Shaping Aperture and Range Compensator 5. Predicate Devices 1. .Decimal Aperture K071077 2. .Decimal Range Compensator K071078 6. Device Description Proton Systems manufactures radiation therapy beam-shaping apert… | 2007 |
| * | K071078 | .Decimal Range CompensatorSummary page 2…market Submission Radiation Therapy Beam-Shaping Aperture and Range Compensator 5. Predicate Devices 1. .Decimal Aperture K071077 2. .Decimal Range Compensator K071078 6. Device Description Proton Systems manufactures radiation therapy beam-shaping apertures and range compensators to customer pa… | 2007 |
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 12 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K132236 (.Decimal, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071077.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy. The apertures and range compensators are designed by the customer's treatment planning system to block radiation from hilling critical structures and healthy tissue while guiding the radiation to the targeted area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121657: Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121657
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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