510(k) · Cleared
ClearedUnscented Menstrual Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unibeauty (Hubei) Technology Co., Ltd. · HEB Tampon, Menstrual, Unscented
Cleared on Dec 15, 2023 as substantially equivalent to K142786 (Ontex Bvba, 2015) after a 109-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it.
- Decided
- Dec 15, 2023
- Review
- 109 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914430 (1993). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK914430 Natracare TamponBodywise (Uk), Ltd. · 1993
- 4 generations backK090098 Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009
- 3 generations backK090819 Ontex Tampon (Unscented)Ontex International NV · 2009
- 2 generations backK122603 Ontex and Other Proprietary NamesOntex Bvba · 2012
- 1 generation backK142786 Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015
- This deviceK232598 Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK251033 Unscented menstrual long applicator tampon; Unscented menstrual…Unibeauty (Hubei) Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253719 Unscented Menstrual Long Applicator Tampon; Unscented Menstrual…Unibeauty (Hubei) Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK252613 Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…Unibeauty (Hubei) Technology Co., Ltd. · 2025 · cites it directly1descendant
- K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…Unibeauty (Hubei) Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914430 | Natracare Tampon | Bodywise (Uk), Ltd. | 1993 | — |
| −4 | K090098 | Maxim Hygiene Organically Grown Cotton Tampon | Maxim Hygiene Products, Inc. | 2009 | — |
| −3 | K090819 | Ontex Tampon (Unscented) | Ontex International NV | 2009 | — |
| −2 | K122603 | Ontex and Other Proprietary Names | Ontex Bvba | 2012 | — |
| −1 | K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | 2015 | — |
| 0 (this device) | K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023 | — |
| +1 | K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact… | Unibeauty (Hubei) Technology Co., Ltd. | 2025 | — |
| +2 | K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard… | Unibeauty (Hubei) Technology Co., Ltd. | 2025 | — |
| +1 | K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K142786 | Ontex Unscented Tampons with Colored Plastic ApplicatorsSummary page 5…e Class: II 3.0 Predicate Device Information The predicate device is Ontex Unscented Tampons with Colored Plastic Applicator manufactured by ONTEX BVBA. 510K Number: K142786 The predicate device has not been subject to any design-related recall. 4.0 Device Description The Unscented Menstrual Tampon… | 2015 |
What descends from it? (3)
2 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 30 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K251033 (Unibeauty (Hubei) Technology Co., Ltd., 2025) has gone furthest, with 1 descendant 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. 2023, 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 Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232598: Unscented Menstrual Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232598
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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