510(k) · Cleared
ClearedProton Positioing and Immobilization Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap · IYE Accelerator, Linear, Medical
Cleared on Jun 29, 2018 as substantially equivalent to K973842 (Medtec, Inc., 1997) after a 177-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Jun 29, 2018
- Review
- 177 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973842 (1997). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK973842 Carbon Fiber Conformal Couch TopMedtec, Inc. · 1997 · Recalled
- This deviceK180021 Proton Positioing and Immobilization DevicesMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap · 2018
- Descendant · cites it directly · 2 of its ownK212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning…Macromedics BV · 2022
- Descendant · 2 generations on · 1 of its ownK222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023
- Descendant · cites it directly · 1 of its ownK211001 C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerMedtec, Inc. Dba Civco Medical Solutions and Civco · 2021
- Descendant · 3 generations on · 0 of its ownK250429 DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate…Macromedics BV · 2025
- Descendant · 2 generations on · 0 of its ownK213439 FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV · 2022
Most influential descendants
Showing 5 of 5 · See all- K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV · 2022 · cites it directly2descendants
- K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023 · 2 generations on1descendant
- K211001C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerMedtec, Inc. Dba Civco Medical Solutions and Civco · 2021 · cites it directly1descendant
- K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…Macromedics BV · 2025 · 3 generations on0descendants
- K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973842 | Carbon Fiber Conformal Couch Top | Medtec, Inc. | 1997 | 7 |
| 0 (this device) | K180021 | Proton Positioing and Immobilization Devices | Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | 2018 | — |
| +1 | K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)… | Macromedics BV | 2022 | — |
| +2 | K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip | Macromedics BV | 2023 | — |
| +1 | K211001 | C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner | Medtec, Inc. Dba Civco Medical Solutions and Civco | 2021 | — |
| +3 | K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)… | Macromedics BV | 2025 | — |
| +2 | K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | Macromedics BV | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K973842 | Carbon Fiber Conformal Couch TopSummary page 4…ces are substantially equivalent to the predicate devices in the following 510(k)s: Predicate Device: Manufacturer K973842: Carbon Fiber Conformal Couch Top MEDTEC, Inc. Reference Devices: K933227: Uni-Frame Head Immobilizatio… | 1997 |
| † | K933227 | Uni-Frame Head Immobilization System | 1994 |
| † | K080072 | Mri Patient Positioning Devices | 2008 |
| † | K060737 | Sinmed Positioning Devices | 2006 |
| † | K982624 | Moldcare Head & Neck Cushion, Model # MT-Acl-14242 | 1998 |
| † | K935300 | Vac-Lok Immobilization System | 1994 |
| † | K121284 | Chabner XRT Garments | 2013 |
| † | K974703 | Carbon Fiber Breast Board | 1998 |
What descends from it? (5)
2 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?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Lok‐Bars, Extensions, Cushions, and Accessories. The following are other positioning devices: Head, Neck, and Shoulders Devices: The device is indicated…
Read the full statement (218 words)
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Lok‐Bars, Extensions, Cushions, and Accessories. The following are other positioning devices:
Head, Neck, and Shoulders Devices: The device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.
Support Garments: The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Breast Positioning Devices: The device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180021: Proton Positioing and Immobilization Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180021
Report an extraction error
Are you the manufacturer?
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