510(k) · Cleared

Cleared

Cryostat

K072414510(k) TraditionalCleared Apr 7, 2008223-day reviewClass U

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

Lil Drug Store Products, Inc. · LKX Device, Thermal, Hemorrhoids

Cleared on Apr 7, 2008 as substantially equivalent to K042564 (Fama Holdings International Corp, 2005) after a 223-day review. Its family tree reaches back 2 generations to 1998.

Decided: Apr 7, 2008
Review: 223 days
Class: Class U
Product code: LKX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K981428 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK981428 Anu IceCryoptherapy Pain Relief Products, Inc. · 1998
1 generation backK042564 Hemor-Rite CryotheraphyFama Holdings International Corp · 2005
This deviceK072414 CryostatLil Drug Store Products, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K981428	Anu Ice	Cryoptherapy Pain Relief Products, Inc.	1998	—
−1	K042564	Hemor-Rite Cryotheraphy	Fama Holdings International Corp	2005	—
0 (this device)	K072414	Cryostat	Lil Drug Store Products, Inc.	2008	—

FIG. 1 — Lineage of K072414, 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
*	K042564	Hemor-Rite Cryotheraphy Summary page 1 …3. Legally Marketed Devices to which Equivalence is Being Claimed Device Name: Hemor-Rite Cryotherapy 510(k) Number: K042564 Applicant: Famna Holdings International Corp. 6202 NW 88th A…	Fama Holdings International Corp	2005	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All LKX devices

LKX Device, Thermal, Hemorrhoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072414: Cryostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072414

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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