510(k) · Cleared

Cleared

Hemor-Rite Cryotheraphy

K042564510(k) TraditionalCleared Sep 30, 2005374-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fama Holdings International Corp · LKX Device, Thermal, Hemorrhoids

Cleared on Sep 30, 2005 as substantially equivalent to K981428 (Cryoptherapy Pain Relief Products, Inc., 1998) after a 374-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Sep 30, 2005
Review: 374 days
Class: Class U
Product code: LKX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K981428 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK981428 Anu IceCryoptherapy Pain Relief Products, Inc. · 1998
This deviceK042564 Hemor-Rite CryotheraphyFama Holdings International Corp · 2005
Descendant · cites it directly · 0 of its ownK072414 CryostatLil Drug Store Products, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K072414CryostatLil Drug Store Products, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981428	Anu Ice	Cryoptherapy Pain Relief Products, Inc.	1998	—
0 (this device)	K042564	Hemor-Rite Cryotheraphy	Fama Holdings International Corp	2005	—
+1	K072414	Cryostat	Lil Drug Store Products, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K042564, 1998–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K981428	Anu Ice Summary page 1 …ssification: Device, Thermal, Hemorrhoids (LKX) 2. Predicate Device: Applicant: Cryotherapy Pain Relief Products, Inc. Proprietary Name: ANUICE 510(k): K981428 3. Device Description and Indications For Use: DESCRIPTION: Hemor-Rite Cryotherapy is an anatomically designed device for…	Cryoptherapy Pain Relief Products, Inc.	1998	—

Also cleared against K981428: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072414	Cryostat	Lil Drug Store Products, Inc.	2008	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K072414 (Lil Drug Store Products, Inc., 2008) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K981428.

How does its category compare?

All LKX devices

LKX Device, Thermal, Hemorrhoids: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKX

1in 2018

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKX

Too few LKX 510(k)s in any year since 2007 to give a median.

Recalls per year · LKX

No recall names LKX since 2007.

Adverse event reports per year · LKX

1in 2023

2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code LKX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042564 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042564: Hemor-Rite Cryotheraphy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042564

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026