510(k) · Cleared
Cleareddecimal Bolus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
.Decimal, LLC · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 1, 2021 as substantially equivalent to K091911 (.Decimal, Inc., 2009) after a 48-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jul 1, 2021
- Review
- 48 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000137 (2000). 9 ancestors in all, the oldest K880047 (1988). 1 later device descends from it, 1 citing it directly.
- 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 backK071078 .Decimal Range Compensator.Decimal, Inc. · 2007
- 1 generation backK091911 Bolus Compensator.Decimal, Inc. · 2009
- This deviceK211511 decimal Bolus.Decimal, LLC · 2021
- Descendant · cites it directly · 0 of its ownK252784 eXaSkin PlusAnatomical Geometry S.L. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252784eXaSkin PlusAnatomical Geometry S.L. · 2026 · cites it directly0descendants
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 | K071078 | .Decimal Range Compensator | .Decimal, Inc. | 2007 | — |
| −1 | K091911 | Bolus Compensator | .Decimal, Inc. | 2009 | — |
| 0 (this device) | K211511 | decimal Bolus | .Decimal, LLC | 2021 | — |
| +1 | K252784 | eXaSkin Plus | Anatomical Geometry S.L. | 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 |
|---|---|---|
| 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K091911 | Bolus CompensatorSummary page 5…s body. As such, these devices will be required to have a wide range of potential shapes and sizes and material properties. Predicate Device: .decimal Bolus Compensator K091911 Intended Use: The decimal Bolus product is placed on the skin of a patient with the intended use and primary purpose of helping… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252784 | eXaSkin Plus | 2026 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K252784 (Anatomical Geometry S.L., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091911.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The decimal Bolus product is a solid piece of material (rigid or rubber-like) that will be placed on the skin of a patient with the intended use and primary purpose of helping control the dose received by that patient when undergoing radiation therapy treatment. decimal Bolus devices are designed by radiation therapy professionals to a unique shape that is specific to each patient being treated. The device is intended to modify the dose delivered during…
Read the full statement (164 words)
The decimal Bolus product is a solid piece of material (rigid or rubber-like) that will be placed on the skin of a patient with the intended use and primary purpose of helping control the dose received by that patient when undergoing radiation therapy treatment. decimal Bolus devices are designed by radiation therapy professionals to a unique shape that is specific to each patient being treated. The device is intended to modify the dose delivered during a radiation therapy treatment. As this product is a simple general purpose bolus device, the intended patient population and indications for use are quite broad. The most common indications for use are for the treatment of patients receiving radiation therapy, which encompasses a wide range of potential disease types and locations. As such, these devices will be required to have a wide range of potential shapes, sizes, and material properties and each device must be tested and approved by the radiation therapy professional prior to use on a patient.
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/K211511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211511: decimal Bolus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211511
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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