510(k) · Cleared
ClearedVSP Bolus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Systems · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Mar 30, 2022 as substantially equivalent to K091911 (.Decimal, Inc., 2009) after a 92-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Mar 30, 2022
- Review
- 92 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000137 (2000). 9 ancestors in all, the oldest K880047 (1988). 2 later devices descend 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 deviceK214093 VSP Bolus3D Systems · 2022
- Descendant · cites it directly · 1 of its ownK222639 VHA Radiotherapy BolusVha Dean · 2022
- Descendant · 2 generations on · 0 of its ownK253025 Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLC · 2026
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 |
|---|---|---|---|---|---|
| −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) | K214093 | VSP Bolus | 3D Systems | 2022 | — |
| +1 | K222639 | VHA Radiotherapy Bolus | Vha Dean | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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 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
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 4…g block Classification: Class II, 21 CFR 892.5710 Product Code: IXI 4. PREDICATE DEVICES Predicate device: BOLUS COMPENSATOR, .DECIMAL INC. (K091911) 5. DESCRIPTION OF THE DEVICE Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222639 | VHA Radiotherapy Bolus | 2022 | 1 |
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 22 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, K222639 (Vha Dean, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K091911.
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. 2022, 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?
The 3D Systems VSP Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VSP Bolus is generated using input from radiation therapy professionals and medical imaging data to produce a bolus that is specific to the patient being treated. The VSP Bolus product is verified and approved by the radiation therapy professional prior to use on the patient, and is intended for patients of all ages receiving radiotherapy treatment.
VSP Bolus was evaluated using 6 MV photons but has not been assessed for use with protons, electrons, or at orthovoltage X-rays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214093: VSP Bolus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214093
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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