510(k) · Cleared
ClearedDSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
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 Feb 17, 2023 as substantially equivalent to K142420 (Macromedics BV, 2015) and 1 other predicate after a 142-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it.
- Decided
- Feb 17, 2023
- Review
- 142 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K905007 (1991). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
- 6 generations backK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
- 5 generations backK060737 Sinmed Positioning DevicesSinmed BV · 2006
- 4 generations backK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- 3 generations backK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- 2 generations backK142420 Patient Positioning DevicesMacromedics BV · 2015
- 1 generation backK212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning…Macromedics BV · 2022
- This deviceK222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023
- Descendant · cites it directly · 0 of its ownK250429 DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate…Macromedics BV · 2025
Most influential descendants
Showing 1 of 1 · See all- K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…Macromedics BV · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K905007 | Standard Breast Boards; Deluxe Breast Board | Bionix Development Corp. | 1991 | — |
| −6 | K030051 | Versaboard, Model 7040 | Bionix Development Corp. | 2003 | — |
| −5 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| −4 | 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 | — |
| −1 | K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)… | Macromedics BV | 2022 | — |
| 0 (this device) | K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip | Macromedics BV | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K142420 | Patient Positioning DevicesSummary page 5…Equivalence is claimed K142420 DSPS & SSPS MacroMedics BV DSPS-Prominent™ thermoplastic masks… | 2015 |
| * | K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsSummary page 5…croMedics BV DSPS-Prominent™ ExaFix-IMRT baseplate, MR baseplate MR K212909 CouchStrips MacroMedics BV CouchStrip 4. Subject Device Description, Intended Use, Tech… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)… | 2025 | 0 |
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 32 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K250429 (Macromedics BV, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K142420.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
DSPS-Prominent Masks, DSPS-Prominent Baseplate, MR:
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment, such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems.
CouchStrip:
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/K222977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222977: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222977
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