510(k) · Cleared
ClearedParcomplast Compensating Filter for Radiation Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S&S Par Scientific · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Dec 27, 2002 as substantially equivalent to K000137 (Computerized Medical Systems, Inc., 2000) and 1 other predicate after a 192-day review. Its family tree reaches back 1 generation to 2000. 16 later devices descend from it.
- Decided
- Dec 27, 2002
- Review
- 192 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000137 (2000). 2 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
- This deviceK021987 Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
- Descendant · cites it directly · 15 of its ownK040804 .Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004
- Descendant · 2 generations on · 9 of its ownK071078 .Decimal Range Compensator.Decimal, Inc. · 2007
- Descendant · 3 generations on · 5 of its ownK091911 Bolus Compensator.Decimal, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK071077 .Decimal Aperture.Decimal, Inc. · 2007
- Descendant · 4 generations on · 2 of its ownK214093 VSP Bolus3D Systems · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K040804.Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004 · cites it directly15descendants
- K071078.Decimal Range Compensator.Decimal, Inc. · 2007 · 2 generations on9descendants
- K091911Bolus Compensator.Decimal, Inc. · 2009 · 3 generations on5descendants
- K071077.Decimal Aperture.Decimal, Inc. · 2007 · 2 generations on4descendants
- K214093VSP Bolus3D Systems · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000137 | Enhanced Compensating Filter | Computerized Medical Systems, Inc. | 2000 | — |
| 0 (this device) | K021987 | Parcomplast Compensating Filter for Radiation Therapy | S&S Par Scientific | 2002 | — |
| +1 | K040804 | .Decimal Tissue Compensator/Intensity Modulator | Southeastern Radiation Products, Inc. | 2004 | — |
| +2 | K071078 | .Decimal Range Compensator | .Decimal, Inc. | 2007 | — |
| +3 | K091911 | Bolus Compensator | .Decimal, Inc. | 2009 | — |
| +2 | K071077 | .Decimal Aperture | .Decimal, Inc. | 2007 | — |
| +4 | K214093 | VSP Bolus | 3D Systems | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K000137 | Enhanced Compensating Filter | 2000 |
| * | K010172 | Lead BlocksSummary page 1…. Predicate Device Information: 1. K#OOOI 37, Enhanced Compensating Filter, Computerized Medical Systems, Inc., St. Louis, MO 2. K#010172, Lead Blocks, Arplay Medical S.A., Cote D'or, France 4. Device Description: ParComPlastTMis a solid block of polyuret… | 2001 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040804 | .Decimal Tissue Compensator/Intensity Modulator | 2004 | 15 |
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?
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.
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?
To shape the beam from a radiation therapy source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021987 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021987: Parcomplast Compensating Filter for Radiation Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021987
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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