# K172358: Instalief

- Pathway: 510(k) (Traditional)
- Applicant: Privi Medical Pte, Ltd.
- Decided: Jan 10, 2018 after 160 days
- Product code: LKX (Device, Thermal, Hemorrhoids)
- Device class: U
- 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 K981428 (1998). 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)
- K981428: Anu Ice, Cryoptherapy Pain Relief Products, Inc. (1998) Summary page 4.

## Indications for use
Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.

Source page: https://510kreport.com/device/K172358
Methodology: https://510kreport.com/methodology