# K160943: Bite Away

- Pathway: 510(k) (Traditional)
- Applicant: Riemser Pharma
- Decided: Aug 26, 2016 after 143 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: 1 generation back to K963824 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963824: Li's Itch Stopper, Hontech Foundation For Medical Technology (1996) Summary page 6.

## Most influential descendants
- K220514: bite away neo (2022), 1 descendant of its own
- K250047: bite away two (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K160943
Methodology: https://510kreport.com/methodology