# K220725: HPR45i

- Pathway: 510(k) (Traditional)
- Applicant: F Care Systems USA, LLC
- Decided: Mar 20, 2023 after 371 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: 3 generations back to K780977 (1978). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081791: E-Z Clean Electrosurgical Electrode, Megadyne Medical Products, Inc. (2008) Summary page 5.

## Most influential descendants
- K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (2025), 0 descendants of its own

## Indications for use
HPR45i electrosurgical electrode is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft issue in a broad range of surgical procedures. The device is a prescription use (Rx) device.

Source page: https://510kreport.com/device/K220725
Methodology: https://510kreport.com/methodology