# K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)

- Pathway: 510(k) (Traditional)
- Applicant: F Care Systems USA, LLC
- Decided: Nov 24, 2025 after 89 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220725: HPR45i, F Care Systems USA, LLC (2023) Summary page 6.
- K210077: MED RF 4000, F Care Systems USA, LLC (2021) Summary page 6.

## Indications for use
F Care RF System is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The devices are prescription use (Rx) devices.

Source page: https://510kreport.com/device/K252704
Methodology: https://510kreport.com/methodology