510(k) · Cleared
ClearedOntex and Others Proprietary Names
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ontex Bvba · HIL Tampon, Menstrual, Scented, Scented-Deodorized
Cleared on Apr 10, 2014 as substantially equivalent to K122603 (Ontex Bvba, 2012) after a 268-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Apr 10, 2014
- Review
- 268 days
- Class
- Class II
- Product code
- HIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914430 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK914430 Natracare TamponBodywise (Uk), Ltd. · 1993
- 3 generations backK090098 Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009
- 2 generations backK090819 Ontex Tampon (Unscented)Ontex International NV · 2009
- 1 generation backK122603 Ontex and Other Proprietary NamesOntex Bvba · 2012
- This deviceK132208 Ontex and Others Proprietary NamesOntex Bvba · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914430 | Natracare Tampon | Bodywise (Uk), Ltd. | 1993 | — |
| −3 | K090098 | Maxim Hygiene Organically Grown Cotton Tampon | Maxim Hygiene Products, Inc. | 2009 | — |
| −2 | K090819 | Ontex Tampon (Unscented) | Ontex International NV | 2009 | — |
| −1 | K122603 | Ontex and Other Proprietary Names | Ontex Bvba | 2012 | — |
| 0 (this device) | K132208 | Ontex and Others Proprietary Names | Ontex Bvba | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122603 | Ontex and Other Proprietary NamesSummary page 3…CARDBOARD APPLICATOR TAMPONS (K12 2603) ____________ 510(k) Number Not yet defined K(122603 __________… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K122603.
How does its category compare?
All HIL devicesHIL Tampon, Menstrual, Scented, Scented-Deodorized: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HIL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIL
Too few HIL 510(k)s in any year since 2007 to give a median.
Recalls per year · HIL
No recall names HIL since 2007.
Adverse event reports per year · HIL
1in 2025
MAUDE reports naming product code HIL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 8 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132208: Ontex and Others Proprietary Names.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132208
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026