510(k) · Cleared
ClearedOntex and other proprietary names
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 Mar 3, 2017 as substantially equivalent to K090819 (Ontex International NV, 2009) after a 154-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Mar 3, 2017
- Review
- 154 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914430 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK914430 Natracare TamponBodywise (Uk), Ltd. · 1993
- 2 generations backK090098 Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009
- 1 generation backK090819 Ontex Tampon (Unscented)Ontex International NV · 2009
- This deviceK162746 Ontex and other proprietary namesOntex Bvba · 2017
- Descendant · cites it directly · 0 of its ownK223883 Daye TamponAnnes Daye, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223883Daye TamponAnnes Daye, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914430 | Natracare Tampon | Bodywise (Uk), Ltd. | 1993 | — |
| −2 | K090098 | Maxim Hygiene Organically Grown Cotton Tampon | Maxim Hygiene Products, Inc. | 2009 | — |
| −1 | K090819 | Ontex Tampon (Unscented) | Ontex International NV | 2009 | — |
| 0 (this device) | K162746 | Ontex and other proprietary names | Ontex Bvba | 2017 | — |
| +1 | K223883 | Daye Tampon | Annes Daye, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K090819 | Ontex Tampon (Unscented)Summary page 5…on, Menstrual, Unscented) Device Class: Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device(s) K090819, Ontex Tampon (Unscented) The predicate device has not been subject to a design-related recall. 6. Device Description Th… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223883 | Daye Tampon | 2023 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K223883 (Annes Daye, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090819.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 W long 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/K162746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162746: Ontex and other 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/K162746
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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