510(k) · Cleared
ClearedAnu Ice
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryoptherapy Pain Relief Products, Inc. · LKX Device, Thermal, Hemorrhoids
Cleared on Jul 7, 1998 after a 78-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jul 7, 1998
- Review
- 78 days
- Class
- Class U
- Product code
- LKX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK981428 Anu IceCryoptherapy Pain Relief Products, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK042564 Hemor-Rite CryotheraphyFama Holdings International Corp · 2005
- Descendant · cites it directly · 0 of its ownK172358 InstaliefPrivi Medical Pte, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK072414 CryostatLil Drug Store Products, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK012746 Ice BatonBehive, Ltd. · 2001
Most influential descendants
Showing 4 of 4 · See all- K042564Hemor-Rite CryotheraphyFama Holdings International Corp · 2005 · cites it directly1descendant
- K172358InstaliefPrivi Medical Pte, Ltd. · 2018 · cites it directly0descendants
- K072414CryostatLil Drug Store Products, Inc. · 2008 · 2 generations on0descendants
- K012746Ice BatonBehive, Ltd. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981428 | Anu Ice | Cryoptherapy Pain Relief Products, Inc. | 1998 | — |
| +1 | K042564 | Hemor-Rite Cryotheraphy | Fama Holdings International Corp | 2005 | — |
| +1 | K172358 | Instalief | Privi Medical Pte, Ltd. | 2018 | — |
| +2 | K072414 | Cryostat | Lil Drug Store Products, Inc. | 2008 | — |
| +1 | K012746 | Ice Baton | Behive, Ltd. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K042564 (Fama Holdings International Corp, 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LKX devicesLKX Device, Thermal, Hemorrhoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981428: Anu Ice.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981428
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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