510(k) · Cleared
ClearedCushionCast Moldable Cushions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Izi Medical Products, LLC · IYE Accelerator, Linear, Medical
Cleared on Nov 15, 2016 as substantially equivalent to K132124 (Klarity Medical Products, LLC, 2013) after a 96-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Nov 15, 2016
- Review
- 96 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895697 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK895697 Vac Fix (R) SystemS&S Par Scientific · 1990
- 2 generations backK040773 Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004
- 1 generation backK132124 Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 2013 · Recalled
- This deviceK162265 CushionCast Moldable CushionsIzi Medical Products, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895697 | Vac Fix (R) System | S&S Par Scientific | 1990 | — |
| −2 | K040773 | Pelvis Bellyboard Plus Patient Positioning System | Bionix Development Corp. | 2004 | — |
| −1 | K132124 | Klarity Vacuum Bag, Klarity Mold Cushion | Klarity Medical Products, LLC | 2013 | 1 |
| 0 (this device) | K162265 | CushionCast Moldable Cushions | Izi Medical Products, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K132124 | Klarity Vacuum Bag, Klarity Mold CushionSummary page 5…Classification Name: Medical charged-particle radiation therapy system (21 CFR 892.5050) Product Code: IYE Predicate Devices Klarity Mold Cushions (K132124) Prior Submissions There were no prior submissions for the subject device. Device Description The CushionCastTM i… | 2013 |
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 4 companies; a new generation was cleared every 9.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The CushionCast Moldable Cushion is to be used by trained medical professionals for stable support and positioning of patients
undergoing radiation therapy or other treatment in a clinic or hospital setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162265 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162265: CushionCast Moldable Cushions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162265
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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