# K971887: Breath Taker

- Pathway: 510(k) (Traditional)
- Applicant: Hofa, LLC
- Decided: Jun 10, 1997 after 20 days
- Product code: LCN (Scraper, Tongue)
- Device class: 1
- Regulation: 21 CFR 872.6855
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Breath Taker is intended to be used for the manual removal of bacteria from the human tongue for the purpose of freshening the breath, enhancing taste-and improving oral hygiene. It is used by placing the selected scraping edge on the back of the extended tongue then pulling forward with sufficient pressure to scrape the tongue and remove bacteria. The Breath Taker is intended for over-the-counter use as a personal hygiene tool by men and women of all ages and physical conditions.

Source page: https://510kreport.com/device/K971887
Methodology: https://510kreport.com/methodology