# K142786: Ontex Unscented Tampons with Colored Plastic Applicators

- Pathway: 510(k) (Traditional)
- Applicant: Ontex Bvba
- Decided: Jun 23, 2015 after 270 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.
4 later devices descend from it; 1 cites it directly.
0 of 10 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.

## Most influential descendants
- 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 Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.

Source page: https://510kreport.com/device/K142786
Methodology: https://510kreport.com/methodology