510(k) Report

FDA applicant

Medtronic Functional Diagnostics A/S

Skovlunde, DK11 decisions1999–20021 recall

FDA records 11 decisions for Medtronic Functional Diagnostics A/S (Skovlunde, DK) from 1999 to 2002: 11 510(k) clearances. Most are in product codes FFX (System, Gastrointestinal Motility (Electrical)) and IKT (Electrode, Needle, Diagnostic Electromyograph). Its devices cite 11 predicates, 1 of them its own earlier devices. 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 Medtronic Functional Diagnostics A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Functional Diagnostics A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medtronic Functional Diagnostics A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Functional Diagnostics A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FFXSystem, Gastrointestinal Motility (Electrical)7decisions
  • IKTElectrode, Needle, Diagnostic Electromyograph2decisions
  • MYESystem, Electrogastrography (Egg)1decision
  • FENDevice, Cystometric, Hydraulic1decision

Whose devices does it build on?

Its devices cite 11 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 1 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.

  • K014269Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102Medtronic Functional Diagnostics A/S · 20022cite it
  • K002992Disposable Hypodermic Needle Electrode, Model…Medtronic Functional Diagnostics A/S · 20012cite it
  • K011472Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf IDMedtronic Functional Diagnostics A/S · 20012cite it
  • K990375Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75Medtronic Functional Diagnostics A/S · 19991cites it
  • K000386Polygram 98 Anorectal Function Testing Application, Model 9043S0111Medtronic Functional Diagnostics A/S · 20001cites it
  • K981733Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111Medtronic Functional Diagnostics A/S · 19991cites it

What has FDA decided for it lately?

  • K014269Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102Medtronic Functional Diagnostics A/S · 2002
  • K011471Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberMedtronic Functional Diagnostics A/S · 2002
  • K002992Disposable Hypodermic Needle Electrode, Model…Medtronic Functional Diagnostics A/S · 2001
  • K011472Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry Application, Polygraf IDMedtronic Functional Diagnostics A/S · 2001
  • K010130Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103Medtronic Functional Diagnostics A/S · 2001
  • K000386Polygram 98 Anorectal Function Testing Application, Model 9043S0111Medtronic Functional Diagnostics A/S · 2000
  • K992715Neuro Urodynamic Suite, Model 9032E0101Medtronic Functional Diagnostics A/S · 2000
  • K992713Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101Medtronic Functional Diagnostics A/S · 1999

All 11 as Medtronic Functional Diagnostics A/S →

What has been recalled?

1 recall linked to its devices; the latest:

  • K981733Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081Apr 28, 2004