# Sterling Medivations, Inc.

- Location (FDA's records): Wayzata, MN
- FDA decisions: 27 (2000–2002): 27 510(k) clearances
- Product codes: FPA (24), FMI (1), FRN (1), FMF (1)
- Predicates its devices cite: 15 (12 its own); citations of its devices by later devices: 14 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Minimed: 2 (https://510kreport.com/company/medtronic-minimed)
- P/L Biomedical: 1 (https://510kreport.com/company/p-l-biomedical)

## Firms that cite its devices most
- Sooil Development Co., Ltd.: 1 (https://510kreport.com/company/sooil-development)
- Spectrx, Inc.: 1 (https://510kreport.com/company/spectrx)

## Its most-cited devices
- K011187: Simplicity Soft YP Infusion Set for Use with the Minimed Paragigm Infusion Pumps (2001), cited by 4
- K014062: Simplicity Easy Access Infusion Set (2002), cited by 2
- K010846: Simplicity Silver Set Soft Infusion (2001), cited by 2
- K013767: Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump (2001), cited by 2
- K010788: Simplicity Soft QD Easy Infusion Set (2001), cited by 1
- K020990: Simplicity Soft QD II Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface of the Skin (2002), cited by 1

## Recent decisions
- K021530: Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface of the Skin (May 21, 2002)
- K021487: Simplicity Easy Access P Infusion Set (May 17, 2002)
- K021296: Simplicity QD Easy P Infusion Set (May 14, 2002)
- K021216: Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion Pumps (May 3, 2002)
- K021005: Simplicity Easy Access II Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface (Apr 25, 2002)
- K020990: Simplicity Soft QD II Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface of the Skin (Apr 10, 2002)
- K020912: Simplicity Easy Soft Infusion Set (Apr 10, 2002)
- K020629: Simplicity Simplex Soft Infusion Set (Apr 1, 2002)

Source page: https://510kreport.com/company/sterling-medivations