Ontex Bvba: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ontex Bvba” (first 2012, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 214 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 114 |
| 2013 | 0 | — |
| 2014 | 2 | 258 |
| 2015 | 1 | 270 |
| 2016 | 0 | — |
| 2017 | 1 | 154 |
| 2018 | 0 | — |
| 2019 | 1 | 182 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ontex Bvba took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 5 | 5 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 1 | 1 |
Review panels
Most recent Ontex Bvba 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191666 | Unscented W long plastic and cardboard applicator tampons | HEB | 2019-12-20 | 182 |
| K162746 | Ontex and other proprietary names | HEB | 2017-03-03 | 154 |
| K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | HEB | 2015-06-23 | 270 |
| K132595 | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS | HEB | 2014-04-23 | 247 |
| K132208 | ONTEX AND OTHERS PROPRIETARY NAMES | HIL | 2014-04-10 | 268 |
| K122603 | ONTEX AND OTHER PROPRIETARY NAMES | HEB | 2012-12-19 | 114 |
Recalls
openFDA lists no recalls under a recalling firm named Ontex Bvba.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ontex International NV (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ontex Bvba?
FDA lists 6 510(k) clearances under the applicant name “Ontex Bvba” (first 2012, latest 2019), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ontex Bvba?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ontex Bvba is 214 days.
Which FDA product codes appear under Ontex Bvba?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 5); HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 1).
Next steps
- See all 6 Ontex Bvba clearances with predicates and recalls
- Run predicate analysis for product code HEB, Ontex Bvba's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.