510(k) · Cleared
ClearedCottons 100% Natural Cotton Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cottons Pty, Ltd. · HEB Tampon, Menstrual, Unscented
Cleared on Feb 18, 2009 as substantially equivalent to K061486 (Procter & Gamble Co., 2006) after a 341-day review. Its family tree reaches back 2 generations to 2004. 12 later devices descend from it.
- Decided
- Feb 18, 2009
- Review
- 341 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040999 (2004). 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK040999 Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)Procter & Gamble Co. · 2004
- 1 generation backK061486 Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies)Procter & Gamble Co. · 2006
- This deviceK080733 Cottons 100% Natural Cotton TamponsCottons Pty, Ltd. · 2009
- Descendant · cites it directly · 11 of its ownK130609 Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013
- Descendant · 2 generations on · 9 of its ownK151170 Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015
- Descendant · 3 generations on · 3 of its ownK231341 Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK182817 CottonDay TamponTaebong Co., Ltd. · 2019
- Descendant · 4 generations on · 1 of its ownK241064 Unscented TamponShandong Intco Hygiene Products Co., Ltd. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K130609Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013 · cites it directly11descendants
- K151170Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015 · 2 generations on9descendants
- K231341Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. · 2023 · 3 generations on3descendants
- K182817CottonDay TamponTaebong Co., Ltd. · 2019 · 3 generations on2descendants
- K241064Unscented TamponShandong Intco Hygiene Products Co., Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040999 | Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2004 | — |
| −1 | K061486 | Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2006 | — |
| 0 (this device) | K080733 | Cottons 100% Natural Cotton Tampons | Cottons Pty, Ltd. | 2009 | — |
| +1 | K130609 | Veeda 100% Cotton Menstrual Tampon | Naturalena Brands, Inc. | 2013 | — |
| +2 | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015 | — |
| +3 | K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023 | — |
| +3 | K182817 | CottonDay Tampon | Taebong Co., Ltd. | 2019 | — |
| +4 | K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K061486 | Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies)Summary page 1…ted menstrual tampon Device Class: II Product code: HEB CFR Reference: 21 CFR 884.5470 Predicate Devices: Tampax®t Tampons, PMN K# 061486 Bentley Biomedical Page 10 of 26 Confidential Consulting, LLC 28… | 2006 |
What descends from it? (12)
See all 122 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 5 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130609 (Naturalena Brands, Inc., 2013) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K061486.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Cottons Ltd, 100% Cotton Tampons are unscented, digital and applicator menstrual tampons for the absorption of menstrual fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080733 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080733: Cottons 100% Natural Cotton Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080733
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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