# K981428: Anu Ice

- Pathway: 510(k) (Traditional)
- Applicant: Cryoptherapy Pain Relief Products, Inc.
- Decided: Jul 7, 1998 after 78 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K042564: Hemor-Rite Cryotheraphy (2005), 1 descendant of its own
- K172358: Instalief (2018), 0 descendants of its own
- K072414: Cryostat (2008), 0 descendants of its own
- K012746: Ice Baton (2001), 0 descendants of its own

## Indications for use
The device use is the treatment of hemorrhoids by applying cold to the anorectal tissues. By applying cold to the tissue, the inflammation is reduced. The cap section is used for the treatment of external hemorrhoids and the tube section for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the rectum.

Source page: https://510kreport.com/device/K981428
Methodology: https://510kreport.com/methodology