510(k) · Cleared
ClearedEnhanced Compensating Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Apr 17, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Apr 17, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
- Descendant · cites it directly · 16 of its ownK021987 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
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K021987Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002 · cites it directly16descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000137 | Enhanced Compensating Filter | Computerized Medical Systems, Inc. | 2000 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 172 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?
- Of its descendants, K021987 (S&S Par Scientific, 2002) has gone furthest, with 16 descendants of its own.
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 | — |
https://510kreport.com/device/K000137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000137: Enhanced Compensating Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000137
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026