510(k) · Cleared
Cleared.Decimal Proton Aperture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
.Decimal, Inc. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Oct 16, 2013 as substantially equivalent to K121657 (Proton Systems, 2012) after a 90-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Oct 16, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000137 (2000). 10 ancestors in all, the oldest K880047 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
- 4 generations backK021987 Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
- 3 generations backK040804 .Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004
- 2 generations backK071077 .Decimal Aperture.Decimal, Inc. · 2007
- 1 generation backK121657 Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion…Proton Systems · 2012
- This deviceK132236 .Decimal Proton Aperture.Decimal, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000137 | Enhanced Compensating Filter | Computerized Medical Systems, Inc. | 2000 | — |
| −4 | K021987 | Parcomplast Compensating Filter for Radiation Therapy | S&S Par Scientific | 2002 | — |
| −3 | K040804 | .Decimal Tissue Compensator/Intensity Modulator | Southeastern Radiation Products, Inc. | 2004 | — |
| −2 | K071077 | .Decimal Aperture | .Decimal, Inc. | 2007 | — |
| −1 | K121657 | Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy… | Proton Systems | 2012 | — |
| 0 (this device) | K132236 | .Decimal Proton Aperture | .Decimal, Inc. | 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 |
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 IXI? 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 IXI device
- #1 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 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 |
|---|---|---|---|
| * | K121657 | Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range…Summary page 2…The operating principles are explained ini section 12 of this submittal. Predicate Device(s): .decimal Proton Aperture (Kl121657), decimal Inc., decimal. Inc. Intended Use: deci mat's Apertutre manutifactuiiri ng service iman… | 2012 |
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 13 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K121657.
How does its category compare?
All IXI devicesIXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IXI
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IXI
90in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IXI
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXI
1in 2016
MAUDE reports naming product code IXI, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 3 | 78 | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 2 | — | 1 | 28 |
| 2012 | 1 | — | 1 | 3 |
| 2013 | 3 | 90 | 2 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
.decimal's Aperture manufacturing service manufactures the ring and solid care apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customers 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/K132236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132236: .Decimal Proton Aperture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132236
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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