510(k) Report

510(k) · Cleared

Cleared

DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set

K250429510(k) TraditionalCleared Mar 19, 202533-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Macromedics BV · IYE Accelerator, Linear, Medical

Cleared on Mar 19, 2025 as substantially equivalent to K222977 (Macromedics BV, 2023) after a 33-day review. Its family tree reaches back 8 generations to 1991.

Decided
Mar 19, 2025
Review
33 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K905007 (1991). 21 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2018: 1 other ancestor2008: 1 other ancestor2002: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor1995: 3 other ancestors1994: 3 other ancestors1993: 1 other ancestorK905007 · Standard Breast Boards; Deluxe Breast Board · Bionix Development Corp. · 1991K030051 · Versaboard, Model 7040 · Bionix Development Corp. · 2003K060737 · Sinmed Positioning Devices · Sinmed BV · 2006K093738 · Mri Patient Positioning Devices · Medtec, Inc. · 2010K111340 · Head and Neck Immobilization System, Body Immobilization System · Medtec, Inc. · 2011K142420 · Patient Positioning Devices · Macromedics BV · 2015K212909 · VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips · Macromedics BV · 2022K222977 · DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip · Macromedics BV · 20231990200020102020
Other ancestors, by generation 3 generations back: 2 other ancestors4 generations back: 11 other ancestors K222977 · DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip · Macromedics BV · 2023K212909 · VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips · Macromedics BV · 2022K142420 · Patient Positioning Devices · Macromedics BV · 2015K111340 · Head and Neck Immobilization System, Body Immobilization System · Medtec, Inc. · 2011K093738 · Mri Patient Positioning Devices · Medtec, Inc. · 2010K060737 · Sinmed Positioning Devices · Sinmed BV · 2006K030051 · Versaboard, Model 7040 · Bionix Development Corp. · 2003K905007 · Standard Breast Boards; Deluxe Breast Board · Bionix Development Corp. · 1991−50
  1. Root · 8 generations backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
  2. 7 generations backK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
  3. 6 generations backK060737 Sinmed Positioning DevicesSinmed BV · 2006
  4. 5 generations backK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
  5. 4 generations backK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
  6. 3 generations backK142420 Patient Positioning DevicesMacromedics BV · 2015
  7. 2 generations backK212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning…Macromedics BV · 2022
  8. 1 generation backK222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023
  9. This deviceK250429 DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate…Macromedics BV · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K905007Standard Breast Boards; Deluxe Breast BoardBionix Development Corp.1991—
−7K030051Versaboard, Model 7040Bionix Development Corp.2003—
−6K060737Sinmed Positioning DevicesSinmed BV2006—
−5K093738Mri Patient Positioning DevicesMedtec, Inc.2010—
−4K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc.2011—
−3K142420Patient Positioning DevicesMacromedics BV2015—
−2K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)…Macromedics BV2022—
−1K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV2023—
0 (this device)K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…Macromedics BV2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199430
199530
199710
199820
200210
200810
201810
FIG. 1 — Lineage of K250429, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
Summary page 7
…Equivalence is claimed K222977 DSPS-Prominent MacroMedics BV DSPS-Prominent Baseplate, MR…
Macromedics BV2023—

What descends from it?

No later submission names this one as a predicate yet.

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 34 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
  • 2 of the 21 ancestors have a recall of any class.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

All devices apart from Handgrips HNS, set/2 (111730):

Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment.

Handgrips HNS, set/2 (111730):

Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Macromedics BV

5 FDA decisions under this applicant name. See the company

  • K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023
  • K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV · 2022
  • K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV · 2022
  • K142420Patient Positioning DevicesMacromedics BV · 2015

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K250429 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250429: DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250429

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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