# K072414: Cryostat

- Pathway: 510(k) (Traditional)
- Applicant: Lil Drug Store Products, Inc.
- Decided: Apr 7, 2008 after 223 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: 2 generations back to K981428 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042564: Hemor-Rite Cryotheraphy, Fama Holdings International Corp (2005) Summary page 1.

## Indications for use
The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/ extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.

Source page: https://510kreport.com/device/K072414
Methodology: https://510kreport.com/methodology