510(k) · Cleared
ClearedBellystep, Headstep, Breaststep, Prostep, Wingstep and Icast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
It-V Medizintechnik, GmbH · IYE Accelerator, Linear, Medical
Cleared on Jul 21, 2008 as substantially equivalent to K991319 (Orfit Industries, 1999) after an 82-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jul 21, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K991319 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991319 Raycast Immobilization Systems Hardware and Thermoplastic MaterialsOrfit Industries · 1999
- This deviceK081218 Bellystep, Headstep, Breaststep, Prostep, Wingstep and IcastIt-V Medizintechnik, GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991319 | Raycast Immobilization Systems Hardware and Thermoplastic Materials | Orfit Industries | 1999 | — |
| 0 (this device) | K081218 | Bellystep, Headstep, Breaststep, Prostep, Wingstep and Icast | It-V Medizintechnik, GmbH | 2008 | — |
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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K060131 | FDA’s K060131 is Oss-Bodies Proximal Tibial Sleeve Our reading of the summary gave K060131, FDA’s number for Oss-Bodies Proximal Tibial Sleeve (Biomet Manufacturing Corp). Its FDA name has none of the distinctive words the summary uses for the device it names, “SINMED Bellyboard System”. Kept off the family tree. Summary page 2…number 8030455) and cleared by FDA with K060131. BellySTEPTM SINMED bellyboard system Positi… | 2006 |
| * | K991319 | Raycast Immobilization Systems Hardware and Thermoplastic MaterialsSummary page 12…c material, manufactured by ORFIT (Registration number 9613183) and cleared by FDA with K991319. Document #: 510 (k) summary.doc Version 1 of 2008-03-28 page 12 of 12 === Page 13 ==… | 1999 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K991319.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 function of the BellySTEP is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics. The function of the HeadSTEP is for fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics. The function of the BreastSTEP is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics. The function of the ProSTEP is for positioning of hip and lower…
Read the full statement (122 words)
The function of the BellySTEP is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics.
The function of the HeadSTEP is for fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics.
The function of the BreastSTEP is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
The function of the ProSTEP is for positioning of hip and lower extremities of a patient for radiotherapy.
The function of the WingSTEP is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
The function of the iCAST thermoplastic materials are for use in retaining and reproducing a patient's position during radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081218: Bellystep, Headstep, Breaststep, Prostep, Wingstep and Icast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081218
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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