510(k) · Cleared
ClearedCold Pack, Plastic Applicator (Medical Grade)-Non-Chemical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryotherapy Products, Inc. · LKX Device, Thermal, Hemorrhoids
Cleared on May 3, 2012 after a 142-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 3, 2012
- Review
- 142 days
- Class
- Class U
- Product code
- LKX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LKX devicesLKX Device, Thermal, Hemorrhoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LKX
1in 2018
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device use is the treatment of hemorrhoids by applying it directly to the swollen Hemorrhoidal 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113660: Cold Pack, Plastic Applicator (Medical Grade)-Non-Chemical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113660
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026