510(k) Report

FDA applicant

Maersk Medical A/S

Fort Worth, TX9 decisions1998–20015 recalls

FDA records 9 decisions for Maersk Medical A/S (Fort Worth, TX) from 1998 to 2001: 9 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and FPA (Set, Administration, Intravascular). Its devices cite 11 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.

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

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

How often FDA has decided Maersk Medical A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Maersk Medical A/S since 2007.

Recalls per year

2in 2014

2009: 12010: 12013: 1, 1 Class I2014: 2
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Maersk Medical A/S 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?

  • DRXElectrode, Electrocardiograph5decisions
  • FPASet, Administration, Intravascular3decisions
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter1decision

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 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.

  • K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 20016cite it
  • K991759Maersk Medical Contour Infusion SetMaersk Medical A/S · 19993cite it
  • K002138Paradigm Silhouette, Models MMT-377, 378, 379, 380Maersk Medical A/S · 20002cite it

What has FDA decided for it lately?

  • K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 20011 Class I recall
  • K002138Paradigm Silhouette, Models MMT-377, 378, 379, 380Maersk Medical A/S · 20002 recalls
  • K990111Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570Maersk Medical A/S · 1999
  • K990112Disposable Ecg Monitoring Electrodes, Models 4060, 4610Maersk Medical A/S · 1999
  • K990115Disposable Ecg Monitoring Electrodes, Models, 4420, 4440Maersk Medical A/S · 1999
  • K990113Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560Maersk Medical A/S · 19991 recall
  • K990110Disposable Ecg Monitoring Electrodes, Model 4110, 4140Maersk Medical A/S · 1999
  • K991759Maersk Medical Contour Infusion SetMaersk Medical A/S · 1999

All 9 as Maersk Medical A/S →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K002138Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"…Nov 7, 2014Class II
  • K002138Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette…Nov 4, 2014Class II
  • K011071Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended…Jun 7, 2013Class I
  • K990113Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoringMar 11, 2010
  • K011071Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The…Jun 29, 2009

Other applicant names beginning “Maersk”

FDA records each applicant name separately; these may or may not be the same firm.

Maersk Medical, Ltd. 4