# K132208: Ontex and Others Proprietary Names

- Pathway: 510(k) (Traditional)
- Applicant: Ontex Bvba
- Decided: Apr 10, 2014 after 268 days
- Product code: HIL ( Tampon, Menstrual, Scented, Scented-Deodorized)
- Device class: 2
- Regulation: 21 CFR 884.5460
- 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 3.

## Indications for use
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.

Source page: https://510kreport.com/device/K132208
Methodology: https://510kreport.com/methodology