# F Care Systems USA, LLC

- Location (FDA's records): Miami, FL
- FDA decisions: 4 (2021–2026): 4 510(k) clearances
- Product codes: GEI (3), ONQ (1)
- 510(k) review time since 2016: median 176 days, against 113 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 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
- Covidien: 2 (https://510kreport.com/company/covidien)
- F Care Systems NV: 1 (https://510kreport.com/company/f-care-systems)
- Newlands Clinical Trials, Ltd.: 1 (https://510kreport.com/company/newlands-clinical-trials)
- Megadyne Medical Products, Inc.: 1 (https://510kreport.com/company/megadyne-medical-products)

## Its most-cited devices
- K210077: MED RF 4000 (2021), cited by 1
- K220725: HPR45i (2023), cited by 1

## Recent decisions
- K253918: Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (Jun 2, 2026)
- K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (Nov 24, 2025)
- K220725: HPR45i (Mar 20, 2023)
- K210077: MED RF 4000 (Dec 17, 2021)

Source page: https://510kreport.com/company/f-care-systems-usa