510(k) · Cleared
ClearedUnscented Menstrual Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qingdao Youjia Hygiene Technology Co., Ltd. · HEB Tampon, Menstrual, Unscented
Cleared on May 9, 2019 as substantially equivalent to K090819 (Ontex International NV, 2009) after a 94-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- May 9, 2019
- Review
- 94 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 deviceK190218 Unscented Menstrual TamponQingdao Youjia Hygiene Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK192557 Youjia Unscented Tampon with Plastic ApplicatorsQingdao Youjia Hygiene Technology Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192557Youjia Unscented Tampon with Plastic ApplicatorsQingdao Youjia Hygiene Technology Co., Ltd. · 2020 · 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) | K190218 | Unscented Menstrual Tampon | Qingdao Youjia Hygiene Technology Co., Ltd. | 2019 | — |
| +1 | K192557 | Youjia Unscented Tampon with Plastic Applicators | Qingdao Youjia Hygiene Technology Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 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 4…oduct code HEB (Tampon, Menstrual, Unscented) 4. Predicate Device Information Trade name Ontex Tampon (Unscented) 510(k) number K090819 The predicate device has not been subject to a design related recall. 1 of 5 === P… | 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 |
|---|---|---|---|
| K192557 | Youjia Unscented Tampon with Plastic Applicators | 2020 | 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 26 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192557 (Qingdao Youjia Hygiene Technology Co., Ltd., 2020) 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. 2019, 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 BiuBiu tampon is inserted into the vagina and used to absorb menstrual and other vaginal discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190218: Unscented Menstrual Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190218
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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