# Maersk Medical A/S

- Location (FDA's records): Fort Worth, TX
- FDA decisions: 9 (1998–2001): 9 510(k) clearances
- Product codes: DRX (5), FPA (3), KNX (1)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 11 (0 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nikomed U.S.A., Inc.: 10 (https://510kreport.com/company/nikomed-usa)
- Zimmar Consulting, Ltd.: 1 (https://510kreport.com/company/zimmar-consulting)

## Firms that cite its devices most
- Unomedical A/S: 9 (https://510kreport.com/company/unomedical-a-s)
- Medtronic Minimed: 1 (https://510kreport.com/company/medtronic-minimed)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Its most-cited devices
- K011071: Paradigm Quick-Set Infusion Set (2001), cited by 6
- K991759: Maersk Medical Contour Infusion Set (1999), cited by 3
- K002138: Paradigm Silhouette, Models MMT-377, 378, 379, 380 (2000), cited by 2

## Recent decisions
- K011071: Paradigm Quick-Set Infusion Set (Jun 7, 2001)
- K002138: Paradigm Silhouette, Models MMT-377, 378, 379, 380 (Aug 29, 2000)
- K990111: Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570 (Dec 6, 1999)
- K990112: Disposable Ecg Monitoring Electrodes, Models 4060, 4610 (Dec 6, 1999)
- K990115: Disposable Ecg Monitoring Electrodes, Models, 4420, 4440 (Dec 6, 1999)
- K990113: Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560 (Dec 6, 1999)
- K990110: Disposable Ecg Monitoring Electrodes, Model 4110, 4140 (Dec 6, 1999)
- K991759: Maersk Medical Contour Infusion Set (Jun 25, 1999)

Source page: https://510kreport.com/company/maersk-medical-a-s