510(k) Report

FDA applicant

Macromedics BV

Moordrecht, NL5 decisions2015–20250 recalls

FDA records 5 decisions for Macromedics BV (Moordrecht, NL) from 2015 to 2025: 5 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 191 days from receipt to decision, against 171 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Macromedics BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12022: 22023: 12025: 1
2015high 2 (2022) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Macromedics BV by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical5decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 191 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 171 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142420Patient Positioning DevicesMacromedics BV · 20155cite it
  • K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV · 20221cites it
  • K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 20231cites it

What has FDA decided for it lately?

  • K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I…Macromedics BV · 2025
  • 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

All 5 as Macromedics BV →