510(k) · Cleared
ClearedTosama 100% Organic Cotton Menstrual Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosama, D.O.O. · HEB Tampon, Menstrual, Unscented
Cleared on Jul 2, 2015 as substantially equivalent to K130609 (Naturalena Brands, Inc., 2013) after a 62-day review. Its family tree reaches back 4 generations to 2004. 9 later devices descend from it.
- Decided
- Jul 2, 2015
- Review
- 62 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040999 (2004). 6 ancestors in all, the oldest K954942 (1996). 9 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK040999 Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)Procter & Gamble Co. · 2004
- 3 generations backK061486 Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies)Procter & Gamble Co. · 2006
- 2 generations backK080733 Cottons 100% Natural Cotton TamponsCottons Pty, Ltd. · 2009
- 1 generation backK130609 Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013
- This deviceK151170 Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015
- Descendant · cites it directly · 3 of its ownK231341 Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK182817 CottonDay TamponTaebong Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK241064 Unscented TamponShandong Intco Hygiene Products Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK252005 Livi DeviceLiviwell, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK242105 SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K231341Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. · 2023 · cites it directly3descendants
- K182817CottonDay TamponTaebong Co., Ltd. · 2019 · cites it directly2descendants
- K241064Unscented TamponShandong Intco Hygiene Products Co., Ltd. · 2025 · 2 generations on1descendant
- K252005Livi DeviceLiviwell, Inc. · 2026 · 3 generations on0descendants
- K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040999 | Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2004 | — |
| −3 | K061486 | Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2006 | — |
| −2 | K080733 | Cottons 100% Natural Cotton Tampons | Cottons Pty, Ltd. | 2009 | — |
| −1 | K130609 | Veeda 100% Cotton Menstrual Tampon | Naturalena Brands, Inc. | 2013 | — |
| 0 (this device) | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015 | — |
| +1 | K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023 | — |
| +1 | K182817 | CottonDay Tampon | Taebong Co., Ltd. | 2019 | — |
| +2 | K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | 2025 | — |
| +3 | K252005 | Livi Device | Liviwell, Inc. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K130609 | Veeda 100% Cotton Menstrual TamponSummary page 4…GULATION NUMBER: 21 CFR §884.5470 PRODUCT CODE: HEB DEVICE CLASS: II PREDICATE DEVICE: Naturalena 100% Cotton Tampon (K130609) DEVICE DESCRIPTION: The device will be offered as a traditional unscented menstrual 100%… | 2013 |
What descends from it? (9)
4 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 11 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K231341 (Zhejiang Tianqing Manufacturing Technology Group Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K130609.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Tosama 100% Organic Cotton Menstrual 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/K151170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151170: Tosama 100% Organic Cotton 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/K151170
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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