# K191666: Unscented W long plastic and cardboard applicator tampons

- Pathway: 510(k) (Traditional)
- Applicant: Ontex Bvba
- Decided: Dec 20, 2019 after 182 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K914430 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122603: Ontex and Other Proprietary Names, Ontex Bvba (2012) Summary page 5.

## Indications for use
The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K191666
Methodology: https://510kreport.com/methodology