510(k) · Cleared
ClearedOntex Roll Wadding Plastic Applicator Compact Size Unscented Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ontex Bvba · HEB Tampon, Menstrual, Unscented
Cleared on Apr 23, 2014 as substantially equivalent to K122603 (Ontex Bvba, 2012) after a 247-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Apr 23, 2014
- Review
- 247 days
- Class
- Class II
- Product code
- HEB
- 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 deviceK132595 Ontex Roll Wadding Plastic Applicator Compact Size Unscented TamponsOntex 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) | K132595 | Ontex Roll Wadding Plastic Applicator Compact Size Unscented Tampons | 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 HEB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HEB device
- #1 K251033 Unscented menstrual long applicator tampon…score 14.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 2…Page 2 of 5 5. Legally Marketed Predicate Device(s) IOntex Digital and Plastic/Cardboard Applicator Unscented Tampons K122603 6. Device Description The Roll wadding plastic Applicator Compact size Unscented Tampon is a menstrual tampon.… | 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 HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HEB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HEB
82in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEB
29in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEB
452in 2025
MAUDE reports naming product code HEB, 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 | 0 | — | 0 | 38 |
| 2008 | 1 | — | 0 | 31 |
| 2009 | 7 | 136 | 0 | 30 |
| 2010 | 3 | 76 | 1 | 138 |
| 2011 | 3 | 28 | 1 | 291 |
| 2012 | 3 | 114 | 0 | 416 |
| 2013 | 2 | — | 0 | 259 |
| 2014 | 4 | 173 | 0 | 167 |
| 2015 | 5 | 114 | 0 | 132 |
| 2016 | 1 | — | 0 | 101 |
| 2017 | 2 | — | 0 | 194 |
| 2018 | 5 | 140 | 4 | 363 |
| 2019 | 7 | 182 | 0 | 3,034 |
| 2020 | 2 | — | 0 | 1,714 |
| 2021 | 6 | 60 | 0 | 1,403 |
| 2022 | 3 | 81 | 0 | 1,055 |
| 2023 | 5 | 109 | 0 | 702 |
| 2024 | 2 | — | 0 | 534 |
| 2025 | 6 | 82 | 29 | 452 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ontex Roll wadding plastic Applicator Compact size Unscented Tampons are inserted into the vagina to absorb menstrual discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132595: Ontex Roll Wadding Plastic Applicator Compact Size Unscented Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132595
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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