# K181986: Klinly Ultrasonic Tongue Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Kea Products, Ltd.
- Decided: Sep 6, 2019 after 408 days
- Product code: QIA (Powered Tongue Scraper)
- Device class: 1
- Regulation: 21 CFR 872.6865
- 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 K980075 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980075: Cybersonic, American Dentronics, Inc. (1998) Summary page 4.

## Indications for use
The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.

Source page: https://510kreport.com/device/K181986
Methodology: https://510kreport.com/methodology