510(k) · Cleared
Cleared3-Way Head Immobilizer; 3WAY Deluxe Reusable Frame Head Immobilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionix Development Corp. · IYE Accelerator, Linear, Medical
Cleared on Oct 7, 1993 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Oct 7, 1993
- Review
- 80 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK933613 3-Way Head Immobilizer; 3WAY Deluxe Reusable Frame Head ImmobilizerBionix Development Corp. · 1993
- Descendant · cites it directly · 17 of its ownK060737 Sinmed Positioning DevicesSinmed BV · 2006
- Descendant · 2 generations on · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- Descendant · 3 generations on · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- Descendant · 2 generations on · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015
- Descendant · 4 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K060737Sinmed Positioning DevicesSinmed BV · 2006 · cites it directly17descendants
- K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · 2 generations on14descendants
- K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 3 generations on13descendants
- K142420Patient Positioning DevicesMacromedics BV · 2015 · 2 generations on7descendants
- K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933613 | 3-Way Head Immobilizer; 3WAY Deluxe Reusable Frame Head Immobilizer | Bionix Development Corp. | 1993 | — |
| +1 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| +2 | K093738 | Mri Patient Positioning Devices | Medtec, Inc. | 2010 | — |
| +3 | K111340 | Head and Neck Immobilization System, Body Immobilization System | Medtec, Inc. | 2011 | — |
| +2 | K142420 | Patient Positioning Devices | Macromedics BV | 2015 | — |
| +4 | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060737 | Sinmed Positioning Devices | 2006 | 17 |
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, K060737 (Sinmed BV, 2006) has gone furthest, with 17 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K933613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933613: 3-Way Head Immobilizer; 3WAY Deluxe Reusable Frame Head Immobilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933613
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026