510(k) · Cleared
Clearedbite away two
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
mibeTec GmbH · IRT Pad, Heating, Powered
Cleared on Sep 12, 2025 as substantially equivalent to K220514 (mibeTec GmbH, 2022) after a 245-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Sep 12, 2025
- Review
- 245 days
- Class
- Class II
- Product code
- IRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963824 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K220514 bite away neoscore 6.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K220514 | bite away neoSummary page 5…740) Regulatory Class 2 Product Code IRT 510(k) Identification K250047 III. PREDICATE DEVICE bite away® neo (K220514) IV. DEVICE DESCRIPTION The mibeTec bite away® two device is a light weight, portable, handheld, battery powered, user-… | 2022 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All IRT devicesIRT Pad, Heating, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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® two 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250047: bite away two.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250047
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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