# K250047: bite away two

- Pathway: 510(k) (Traditional)
- Applicant: mibeTec GmbH
- Decided: Sep 12, 2025 after 245 days
- Product code: IRT (Pad, Heating, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963824 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220514: bite away neo, mibeTec GmbH (2022) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250047
Methodology: https://510kreport.com/methodology