510(k) · Cleared
ClearedOrganic cotton tampon, Viscose tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. · HEB Tampon, Menstrual, Unscented
Cleared on Aug 14, 2023 as substantially equivalent to K151170 (Tosama, D.O.O., 2015) after a 97-day review. Its family tree reaches back 5 generations to 2004. 3 later devices descend from it.
- Decided
- Aug 14, 2023
- Review
- 97 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K040999 (2004). 7 ancestors in all, the oldest K954942 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK040999 Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)Procter & Gamble Co. · 2004
- 4 generations backK061486 Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies)Procter & Gamble Co. · 2006
- 3 generations backK080733 Cottons 100% Natural Cotton TamponsCottons Pty, Ltd. · 2009
- 2 generations backK130609 Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013
- 1 generation backK151170 Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015
- This deviceK231341 Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241064 Unscented TamponShandong Intco Hygiene Products Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252005 Livi DeviceLiviwell, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK242105 SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K040999 | Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2004 | — |
| −4 | K061486 | Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2006 | — |
| −3 | K080733 | Cottons 100% Natural Cotton Tampons | Cottons Pty, Ltd. | 2009 | — |
| −2 | K130609 | Veeda 100% Cotton Menstrual Tampon | Naturalena Brands, Inc. | 2013 | — |
| −1 | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015 | — |
| 0 (this device) | K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023 | — |
| +1 | K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | 2025 | — |
| +2 | K252005 | Livi Device | Liviwell, Inc. | 2026 | — |
| +1 | K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K151170 | Tosama 100% Organic Cotton Menstrual TamponSummary page 4…Regulation No. 21 CFR 884.5470 3. Legally Marketed Predicate Device Trade Name Tosama 100% Organic Cotton Menstrual Tampon 510(k) Number K151170 Product Code HEB Manufacturer TOSAMA, d.o.o. Design Related Recall None 4. Device Description… | 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 19 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K241064 (Shandong Intco Hygiene Products Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K151170.
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 tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231341: Organic cotton tampon, Viscose tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231341
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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