# K042564: Hemor-Rite Cryotheraphy

- Pathway: 510(k) (Traditional)
- Applicant: Fama Holdings International Corp
- Decided: Sep 30, 2005 after 374 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 1.

## Most influential descendants
- K072414: Cryostat (2008), 0 descendants of its own

## Indications for use
The device use is for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying the device to the tissue, the inflammation is reduced. The base section is used for the treatment of external hemorrhoids and the neck/probe section is used for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the probe into the rectum.

Source page: https://510kreport.com/device/K042564
Methodology: https://510kreport.com/methodology