510(k) · Cleared
ClearedUnscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
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 17, 2025 as substantially equivalent to K251033 (Unibeauty (Hubei) Technology Co., Ltd., 2025) after a 23-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Dec 17, 2025
- Review
- 23 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K914430 (1993). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK914430 Natracare TamponBodywise (Uk), Ltd. · 1993
- 6 generations backK090098 Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009
- 5 generations backK090819 Ontex Tampon (Unscented)Ontex International NV · 2009
- 4 generations backK122603 Ontex and Other Proprietary NamesOntex Bvba · 2012
- 3 generations backK142786 Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015
- 2 generations backK232598 Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023
- 1 generation backK251033 Unscented menstrual long applicator tampon; Unscented menstrual…Unibeauty (Hubei) Technology Co., Ltd. · 2025
- This deviceK253719 Unscented Menstrual Long Applicator Tampon; Unscented Menstrual…Unibeauty (Hubei) Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914430 | Natracare Tampon | Bodywise (Uk), Ltd. | 1993 | — |
| −6 | K090098 | Maxim Hygiene Organically Grown Cotton Tampon | Maxim Hygiene Products, Inc. | 2009 | — |
| −5 | K090819 | Ontex Tampon (Unscented) | Ontex International NV | 2009 | — |
| −4 | K122603 | Ontex and Other Proprietary Names | Ontex Bvba | 2012 | — |
| −3 | K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | 2015 | — |
| −2 | 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 | — |
| 0 (this device) | K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard… | Unibeauty (Hubei) Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…Summary page 5…n Unscented Menstrual Digital Tampons Classification Name: Tampon, Menstrual, Unscented Product Code: HEB Regulation: 21 CFR 884.5470 Device Class: II 510k Number: K251033 III．Reason of submission 1) Device size change; 2) Device design change 1 / 9 =… | 2025 |
| † | K232598 | Unscented Menstrual Tampon | 2023 |
| † | K252613 | Unscented menstrual three-piece applicator tampon | 2025 |
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 32 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Tampons are inserted into the vagina to absorb menstrual discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253719: Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253719
Report an extraction error
Are you the manufacturer?
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