# K122603: Ontex and Other Proprietary Names

- Pathway: 510(k) (Traditional)
- Applicant: Ontex Bvba
- Decided: Dec 19, 2012 after 114 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.
8 later devices descend from it; 4 cite it directly.
0 of 13 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 1.

## Most influential descendants
- K142786: Ontex Unscented Tampons with Colored Plastic Applicators (2015), 4 descendants of its own
- K232598: Unscented Menstrual Tampon (2023), 3 descendants of its own
- K251033: Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons (2025), 1 descendant of its own
- K253719: Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (2025), 0 descendants of its own
- K252613: Unscented menstrual three-piece applicator tampon (2025), 0 descendants of its own

## Indications for use
The Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons, Available in light, regular, super, and super plus absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K122603
Methodology: https://510kreport.com/methodology