# K992995: Aromatic and Flavored Tongue Depressor

- Pathway: 510(k) (Traditional)
- Applicant: Aga Plastic Ind. Com. Ltda.
- Decided: Dec 9, 1999 after 93 days
- Product code: FMA (Depressor, Tongue, Non-Surgical)
- Device class: 1
- Regulation: 21 CFR 880.6230
- 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 K842461 (1984). 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)
- K842461: Tongue Depressor, The Torrent Corp. (1984) Summary page 1.

## Indications for use
The Aromatic and Flavored Tongue Depressor is intended to displace the tongue to facilitate examination of the surrounding organs. They are available in the following colors: Ycllow. blue. orange, magenta. pink. green and red.

Source page: https://510kreport.com/device/K992995
Methodology: https://510kreport.com/methodology