510(k) · Cleared
Clearedbite away neo
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 Jun 23, 2022 as substantially equivalent to K160943 (Riemser Pharma, 2016) after a 121-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 23, 2022
- Review
- 121 days
- Class
- Class II
- Product code
- IRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963824 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K250047bite away twomibeTec GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963824 | Li's Itch Stopper | Hontech Foundation For Medical Technology | 1996 | — |
| −1 | K160943 | Bite Away | Riemser Pharma | 2016 | — |
| 0 (this device) | K220514 | bite away neo | mibeTec GmbH | 2022 | — |
| +1 | K250047 | bite away two | mibeTec GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K160943 | Bite AwaySummary page 4…5740) Name Regulatory Class: II Product Code: IRT 510(K) Identification: K220514 III. PREDICATE DEVICE Riemser Bite Away, K160943 IV. DEVICE DESCRIPTION Design Characteristics The bite away® neo device is a light weight, portable, hand-held, battery powe… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250047 | bite away two | 2025 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 19.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250047 (mibeTec GmbH, 2025) has gone furthest, with 0 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. 2022, 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® neo 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/K220514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220514: bite away neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220514
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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