510(k) · Cleared
ClearedTosama 100% 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 Apr 20, 2015 as substantially equivalent to K130609 (Naturalena Brands, Inc., 2013) and 1 other predicate after an 18-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Apr 20, 2015
- Review
- 18 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K040999 (2004). 6 ancestors in all, the oldest K954942 (1996). No later device cites it as a predicate yet.
- 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 deviceK150897 Tosama 100% Cotton Menstrual TamponTosama, D.O.O. · 2015
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) | K150897 | Tosama 100% Cotton Menstrual Tampon | Tosama, D.O.O. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2009 | 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? (2)
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…TION NUMBER: 21 CFR §884.5470 PRODUCT CODE: HEB DEVICE CLASS: II PREDICATE DEVICES: Naturalena 100% Cotton Tampon (K130609) Cottons 100% Natural Cotton Tampon (K080733) DEVICE DESCRIPTION: The device will be off… | 2013 |
| * | K080733 | Cottons 100% Natural Cotton TamponsSummary page 4…DEVICE CLASS: II PREDICATE DEVICES: Naturalena 100% Cotton Tampon (K130609) Cottons 100% Natural Cotton Tampon (K080733) DEVICE DESCRIPTION: The device will be offered as a traditional unscented menstrual 100… | 2009 |
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 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.
- 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% Cotton Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150897 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150897: Tosama 100% Cotton Menstrual Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150897
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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