510(k) · Cleared
ClearedLi's Itch Stopper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hontech Foundation For Medical Technology · IRT Pad, Heating, Powered
Cleared on Dec 12, 1996 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 12, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- IRT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK963824 Li's Itch StopperHontech Foundation For Medical Technology · 1996
- Descendant · cites it directly · 2 of its ownK160943 Bite AwayRiemser Pharma · 2016
- Descendant · 2 generations on · 1 of its ownK220514 bite away neomibeTec GmbH · 2022
- Descendant · 3 generations on · 0 of its ownK250047 bite away twomibeTec GmbH · 2025
- Descendant · cites it directly · 0 of its ownK964397 TherapikThe Jenex Corporation · 1997
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963824 | Li's Itch Stopper | Hontech Foundation For Medical Technology | 1996 | — |
| +1 | K160943 | Bite Away | Riemser Pharma | 2016 | — |
| +2 | K220514 | bite away neo | mibeTec GmbH | 2022 | — |
| +3 | K250047 | bite away two | mibeTec GmbH | 2025 | — |
| +1 | K964397 | Therapik | The Jenex Corporation | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IRT device
- #1 K250047 bite away twoscore 10.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 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, K160943 (Riemser Pharma, 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IRT devicesIRT Pad, Heating, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRT
Too few IRT 510(k)s in any year since 2007 to give a median.
Recalls per year · IRT
3in 2022
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · IRT
70in 2025
MAUDE reports naming product code IRT, 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 | — | 5 | 312 |
| 2008 | 1 | — | 0 | 242 |
| 2009 | 0 | — | 0 | 555 |
| 2010 | 0 | — | 0 | 413 |
| 2011 | 1 | — | 0 | 227 |
| 2012 | 0 | — | 0 | 233 |
| 2013 | 0 | — | 0 | 345 |
| 2014 | 1 | — | 0 | 414 |
| 2015 | 1 | — | 0 | 289 |
| 2016 | 1 | — | 1 | 182 |
| 2017 | 0 | — | 0 | 220 |
| 2018 | 0 | — | 0 | 325 |
| 2019 | 0 | — | 0 | 205 |
| 2020 | 0 | — | 0 | 117 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 3 (3) | 134 |
| 2023 | 0 | — | 0 | 321 |
| 2024 | 0 | — | 0 | 77 |
| 2025 | 1 | — | 0 | 70 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K963824 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963824: Li's Itch Stopper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963824
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026