510(k) · Cleared
ClearedVac-Lok Immobilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jul 18, 1994 after a 258-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.
- Decided
- Jul 18, 1994
- Review
- 258 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 4 citing it directly.
- This deviceK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- Descendant · cites it directly · 17 of its ownK060737 Sinmed Positioning DevicesSinmed BV · 2006
- Descendant · cites it directly · 15 of its ownK080072 Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008
- Descendant · 2 generations on · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- Descendant · 2 generations on · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- Descendant · cites it directly · 13 of its ownK960338 Stereotactic Body FrameElekta Instrument AB · 1996
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K060737Sinmed Positioning DevicesSinmed BV · 2006 · cites it directly17descendants
- K080072Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008 · cites it directly15descendants
- K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · 2 generations on14descendants
- K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 2 generations on13descendants
- K960338Stereotactic Body FrameElekta Instrument AB · 1996 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935300 | Vac-Lok Immobilization System | Medtec, Inc. | 1994 | — |
| +1 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| +1 | K080072 | Mri Patient Positioning Devices | CIVCO Medical Instruments Co., Inc. | 2008 | — |
| +2 | K093738 | Mri Patient Positioning Devices | Medtec, Inc. | 2010 | — |
| +2 | K111340 | Head and Neck Immobilization System, Body Immobilization System | Medtec, Inc. | 2011 | — |
| +1 | K960338 | Stereotactic Body Frame | Elekta Instrument AB | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (31)
See all 314 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, 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/K935300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935300: Vac-Lok Immobilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935300
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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