510(k) Report

FDA applicant

Medical Measurement Systems B.V.

Enschede Overijssel, NL7 decisions2004–20121 recall

FDA records 7 decisions for Medical Measurement Systems B.V. (Enschede Overijssel, NL) from 2004 to 2012: 7 510(k) clearances. Most are in product codes FFX (System, Gastrointestinal Motility (Electrical)) and LLZ (System, Image Processing, Radiological). 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Medical Measurement Systems B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Measurement Systems B.V. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FFXSystem, Gastrointestinal Motility (Electrical)5decisions
  • LLZSystem, Image Processing, Radiological1decision
  • GWFStimulator, Electrical, Evoked Response1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K052338Solar GIMedical Measurement Systems B.V. · 20052cite it
  • K121014Solar GIMedical Measurement Systems B.V. · 20121cites it

What has FDA decided for it lately?

  • K121014Solar GIMedical Measurement Systems B.V. · 20121 recall
  • K071094Modification to Solar GIMedical Measurement Systems B.V. · 2007
  • K060166OhmegaMedical Measurement Systems B.V. · 2006
  • K052338Solar GIMedical Measurement Systems B.V. · 2005
  • K050993MMS Video OptionMedical Measurement Systems B.V. · 2005
  • K031084Solar GI SystemMedical Measurement Systems B.V. · 2004
  • K031930High Speed Emg ModuleMedical Measurement Systems B.V. · 2004

All 7 as Medical Measurement Systems B.V. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K121014Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p…May 21, 2026Class II