510(k) · Cleared
ClearedOntex Tampon (Unscented)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ontex International NV · HEB Tampon, Menstrual, Unscented
Cleared on Dec 23, 2009 as substantially equivalent to K090098 (Maxim Hygiene Products, Inc., 2009) after a 273-day review. Its family tree reaches back 2 generations to 1993. 13 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 273 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914430 (1993). 3 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK914430 Natracare TamponBodywise (Uk), Ltd. · 1993
- 1 generation backK090098 Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009
- This deviceK090819 Ontex Tampon (Unscented)Ontex International NV · 2009
- Descendant · cites it directly · 8 of its ownK122603 Ontex and Other Proprietary NamesOntex Bvba · 2012
- Descendant · 2 generations on · 4 of its ownK142786 Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015
- Descendant · 3 generations on · 3 of its ownK232598 Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK251033 Unscented menstrual long applicator tampon; Unscented menstrual…Unibeauty (Hubei) Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK190218 Unscented Menstrual TamponQingdao Youjia Hygiene Technology Co., Ltd. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K122603Ontex and Other Proprietary NamesOntex Bvba · 2012 · cites it directly8descendants
- K142786Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015 · 2 generations on4descendants
- K232598Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023 · 3 generations on3descendants
- K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…Unibeauty (Hubei) Technology Co., Ltd. · 2025 · 4 generations on1descendant
- K190218Unscented Menstrual TamponQingdao Youjia Hygiene Technology Co., Ltd. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914430 | Natracare Tampon | Bodywise (Uk), Ltd. | 1993 | — |
| −1 | K090098 | Maxim Hygiene Organically Grown Cotton Tampon | Maxim Hygiene Products, Inc. | 2009 | — |
| 0 (this device) | K090819 | Ontex Tampon (Unscented) | Ontex International NV | 2009 | — |
| +1 | K122603 | Ontex and Other Proprietary Names | Ontex Bvba | 2012 | — |
| +2 | K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | 2015 | — |
| +3 | K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023 | — |
| +4 | K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact… | Unibeauty (Hubei) Technology Co., Ltd. | 2025 | — |
| +1 | K190218 | Unscented Menstrual Tampon | Qingdao Youjia Hygiene Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K090098 | Maxim Hygiene Organically Grown Cotton TamponSummary page 1…(Unscented) Device Class: II ~gulation: 884.5470 rroduct Code: HEB 3. Predicate Device Information: Maxim Hygeine Organically Grown Cotton Tampon 5 10(k) Number: K090098 Maxim Hygeine Products. 39 Maple Street Roslyn Heights, NY 11577-1941 4. Device Description: The tampons to be marketed are con… | 2009 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K122603 (Ontex Bvba, 2012) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090819 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090819: Ontex Tampon (Unscented).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090819
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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