# K252260: RELIEEV HSG Catheter (HSG7FA1)

- Pathway: 510(k) (Traditional)
- Applicant: Li Medical Corporation, Ltd.
- Decided: Nov 26, 2025 after 128 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092983 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092983: Panpac HSG Catheter Set, Panpac Medical Corporation (2010) Summary page 5.

## Indications for use
The RELIEEV HSG Catheter (HSG7FA1) is for the delivery of contrast media or saline into the uterine cavity during hysterosalpingography or sonohysterography for examination of the uterus and fallopian tubes.

Source page: https://510kreport.com/device/K252260
Methodology: https://510kreport.com/methodology