# Ontex Bvba

- Location (FDA's records): Buggenhout Oost - Vlaanderen, BE
- FDA decisions: 6 (2012–2019): 6 510(k) clearances
- Product codes: HEB (5), HIL (1)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ontex International NV: 2 (https://510kreport.com/company/ontex-international)

## Firms that cite its devices most
- Annes Daye, Ltd.: 1 (https://510kreport.com/company/annes-daye)
- Unibeauty (Hubei) Technology Co., Ltd.: 1 (https://510kreport.com/company/unibeauty-hubei-technology)

## Its most-cited devices
- K122603: Ontex and Other Proprietary Names (2012), cited by 4
- K142786: Ontex Unscented Tampons with Colored Plastic Applicators (2015), cited by 1
- K162746: Ontex and other proprietary names (2017), cited by 1

## Recent decisions
- K191666: Unscented W long plastic and cardboard applicator tampons (Dec 20, 2019)
- K162746: Ontex and other proprietary names (Mar 3, 2017)
- K142786: Ontex Unscented Tampons with Colored Plastic Applicators (Jun 23, 2015)
- K132595: Ontex Roll Wadding Plastic Applicator Compact Size Unscented Tampons (Apr 23, 2014)
- K132208: Ontex and Others Proprietary Names (Apr 10, 2014)
- K122603: Ontex and Other Proprietary Names (Dec 19, 2012)

Source page: https://510kreport.com/company/ontex