# K162746: Ontex and other proprietary names

- Pathway: 510(k) (Traditional)
- Applicant: Ontex Bvba
- Decided: Mar 3, 2017 after 154 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: 3 generations back to K914430 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090819: Ontex Tampon (Unscented), Ontex International NV (2009) Summary page 5.

## Most influential descendants
- K223883: Daye Tampon (2023), 0 descendants of its own

## Indications for use
The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.

Source page: https://510kreport.com/device/K162746
Methodology: https://510kreport.com/methodology