510(k) · Cleared
ClearedeXaSkin Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anatomical Geometry S.L. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 22, 2026 as substantially equivalent to K211511 (.Decimal, LLC, 2021) after a 262-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- May 22, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000137 (2000). 10 ancestors in all, the oldest K880047 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
- 5 generations backK021987 Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
- 4 generations backK040804 .Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004
- 3 generations backK071078 .Decimal Range Compensator.Decimal, Inc. · 2007
- 2 generations backK091911 Bolus Compensator.Decimal, Inc. · 2009
- 1 generation backK211511 decimal Bolus.Decimal, LLC · 2021
- This deviceK252784 eXaSkin PlusAnatomical Geometry S.L. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000137 | Enhanced Compensating Filter | Computerized Medical Systems, Inc. | 2000 | — |
| −5 | K021987 | Parcomplast Compensating Filter for Radiation Therapy | S&S Par Scientific | 2002 | — |
| −4 | K040804 | .Decimal Tissue Compensator/Intensity Modulator | Southeastern Radiation Products, Inc. | 2004 | — |
| −3 | K071078 | .Decimal Range Compensator | .Decimal, Inc. | 2007 | — |
| −2 | K091911 | Bolus Compensator | .Decimal, Inc. | 2009 | — |
| −1 | K211511 | decimal Bolus | .Decimal, LLC | 2021 | — |
| 0 (this device) | 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 |
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.
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 26 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
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. 2026, 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?
eXaSkin is a medical device intended to be used as a bolus for the treatment of neoplastic skin lesions through radiotherapy. The product is designed to be applied to the irradiated area by qualified healthcare professionals to address anatomical irregularities and ensure precise delivery of the prescribed dose to the skin and underlying tissues during a radiation therapy treatment.
eXaSkin was evaluated using 6 MV photons but has not been assessed for use with 10 MV photons, protons, or orthovoltage X-rays.
eXaSkin Plus 150 and 225 is intended for general radiotherapy use.
eXaSkin Plus 650 is intended for use on breast tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252784: eXaSkin Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252784
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026