510(k) · Cleared
ClearedVacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macromedics BV · IYE Accelerator, Linear, Medical
Cleared on May 11, 2022 as substantially equivalent to K180021 (Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap, 2018) and 1 other predicate after a 240-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.
- Decided
- May 11, 2022
- Review
- 240 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K905007 (1991). 19 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
- 5 generations backK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
- 4 generations backK060737 Sinmed Positioning DevicesSinmed BV · 2006
- 3 generations backK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- 2 generations backK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- 1 generation backK142420 Patient Positioning DevicesMacromedics BV · 2015
- This deviceK212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning…Macromedics BV · 2022
- Descendant · cites it directly · 1 of its ownK222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023
- Descendant · 2 generations on · 0 of its ownK250429 DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate…Macromedics BV · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K905007 | Standard Breast Boards; Deluxe Breast Board | Bionix Development Corp. | 1991 | — |
| −5 | K030051 | Versaboard, Model 7040 | Bionix Development Corp. | 2003 | — |
| −4 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| −3 | K093738 | Mri Patient Positioning Devices | Medtec, Inc. | 2010 | — |
| −2 | K111340 | Head and Neck Immobilization System, Body Immobilization System | Medtec, Inc. | 2011 | — |
| −1 | K142420 | Patient Positioning Devices | Macromedics BV | 2015 | — |
| 0 (this device) | K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)… | Macromedics BV | 2022 | — |
| +1 | K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip | Macromedics BV | 2023 | — |
| +2 | K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)… | Macromedics BV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180021 | Proton Positioing and Immobilization DevicesSummary page 5…of 6 Review Panel: Radiology 3. Predicate Device Details 510k Number Device Name Manufacturer K180021 Cushions (Vac-Lok) MEDTEC, Inc. d/b/a “CIVCO Medical… | 2018 |
| * | K142420 | Patient Positioning DevicesSummary page 5…Cushions (Vac-Lok) MEDTEC, Inc. d/b/a “CIVCO Medical Solutions” and “CIVCO Radiotherapy” K142420 LEPS (Lower Extremities MacroMedics BV Positioning System), FeetSup… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip | 2023 | 1 |
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 31 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K222977 (Macromedics BV, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K180021.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Both the Intended Use and the Indications for Use of the devices included in this submission are as follows:
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212909
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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