510(k) · Cleared
ClearedIce Baton
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behive, Ltd. · LKX Device, Thermal, Hemorrhoids
Cleared on Nov 14, 2001 as substantially equivalent to K981428 (Cryoptherapy Pain Relief Products, Inc., 1998) after a 90-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 14, 2001
- Review
- 90 days
- Class
- Class U
- Product code
- LKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981428 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981428 Anu IceCryoptherapy Pain Relief Products, Inc. · 1998
- This deviceK012746 Ice BatonBehive, Ltd. · 2001
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) | K012746 | Ice Baton | Behive, Ltd. | 2001 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K981428 | Anu IceSummary page 1…: Ice Baton Common/Usual Name: Hemorrhoid Device Classification Name: Thermal Hemorrhoid Device 3. PREDICATE DEVICES Cryotherapy Pain Relief Products, Inc.- Anulce - K981428 4, DEVICE DESCRIPTION The Ice Baton is a suppository-shaped medical device designed to provide relief from the pain and discomf… | 1998 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K981428.
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 Ice Baton is intended to provide relief from pain and discomfort due to hemorthoids
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/K012746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012746: Ice Baton.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012746
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026