510(k) · Cleared
ClearedBolus Compensator
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 Jul 21, 2009 as substantially equivalent to K071078 (.Decimal, Inc., 2007) after a 26-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Jul 21, 2009
- Review
- 26 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000137 (2000). 8 ancestors in all, the oldest K880047 (1988). 5 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 backK071078 .Decimal Range Compensator.Decimal, Inc. · 2007
- This deviceK091911 Bolus Compensator.Decimal, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK214093 VSP Bolus3D Systems · 2022
- Descendant · 2 generations on · 1 of its ownK222639 VHA Radiotherapy BolusVha Dean · 2022
- Descendant · cites it directly · 1 of its ownK211511 decimal Bolus.Decimal, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK252784 eXaSkin PlusAnatomical Geometry S.L. · 2026
- Descendant · 3 generations on · 0 of its ownK253025 Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLC · 2026
Most influential descendants
Showing 5 of 5 · See all- K214093VSP Bolus3D Systems · 2022 · cites it directly2descendants
- K222639VHA Radiotherapy BolusVha Dean · 2022 · 2 generations on1descendant
- K211511decimal Bolus.Decimal, LLC · 2021 · cites it directly1descendant
- K252784eXaSkin PlusAnatomical Geometry S.L. · 2026 · 2 generations on0descendants
- K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLC · 2026 · 3 generations on0descendants
View 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 | K071078 | .Decimal Range Compensator | .Decimal, Inc. | 2007 | — |
| 0 (this device) | K091911 | Bolus Compensator | .Decimal, Inc. | 2009 | — |
| +1 | K214093 | VSP Bolus | 3D Systems | 2022 | — |
| +2 | K222639 | VHA Radiotherapy Bolus | Vha Dean | 2022 | — |
| +1 | K211511 | decimal Bolus | .Decimal, LLC | 2021 | — |
| +2 | K252784 | eXaSkin Plus | Anatomical Geometry S.L. | 2026 | — |
| +3 | K253025 | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 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 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 |
|---|---|---|---|
| * | K071078 | .Decimal Range CompensatorSummary page 1…fication Name: IXI 21 CFR892.5710 Class II Predicate Device(s): .decimal Range Compensator (K071078) decimnol 'he benchmark for custom radiation therapy Intended Use: .decimal.'… | 2007 |
What descends from it? (5)
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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K214093 (3D Systems, 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K071078.
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. 2009, 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?
Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091911: Bolus Compensator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091911
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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