# K090819: Ontex Tampon (Unscented)

- Pathway: 510(k) (Abbreviated)
- Applicant: Ontex International NV
- Decided: Dec 23, 2009 after 273 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: 2 generations back to K914430 (1993). 3 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090098: Maxim Hygiene Organically Grown Cotton Tampon, Maxim Hygiene Products, Inc. (2009) Summary page 1.

## Most influential descendants
- K122603: Ontex and Other Proprietary Names (2012), 8 descendants of its own
- 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
- K190218: Unscented Menstrual Tampon (2019), 1 descendant of its own

## Indications for use
Ontex Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

Source page: https://510kreport.com/device/K090819
Methodology: https://510kreport.com/methodology