510(k) · Cleared
ClearedBite Away
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riemser Pharma · IRT Pad, Heating, Powered
Cleared on Aug 26, 2016 as substantially equivalent to K963824 (Hontech Foundation For Medical Technology, 1996) after a 143-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Aug 26, 2016
- Review
- 143 days
- Class
- Class II
- Product code
- IRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963824 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK963824 Li's Itch StopperHontech Foundation For Medical Technology · 1996
- This deviceK160943 Bite AwayRiemser Pharma · 2016
- Descendant · cites it directly · 1 of its ownK220514 bite away neomibeTec GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK250047 bite away twomibeTec GmbH · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963824 | Li's Itch Stopper | Hontech Foundation For Medical Technology | 1996 | — |
| 0 (this device) | K160943 | Bite Away | Riemser Pharma | 2016 | — |
| +1 | K220514 | bite away neo | mibeTec GmbH | 2022 | — |
| +2 | K250047 | bite away two | mibeTec GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K963824 | Li's Itch StopperSummary page 6…D PRODUCT The Riemser Pharma Bite Away device shares a similar intended use and design principles with the following primary predicate device Hontech Li’s Itch Stopper (K963824), which have been determined by FDA to be substantially equivalent to the Bite Away device. The Jenex Therapik (K964397) was used… | 1996 |
| † | K964397 | Therapik | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220514 | bite away neo | 2022 | 1 |
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?
How does its category compare?
All IRT devicesIRT Pad, Heating, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Bite Away is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by temporarily increasing localized blood flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160943 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160943: Bite Away.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160943
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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