510(k) · Cleared
ClearedTampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble Co. · HEB Tampon, Menstrual, Unscented
Cleared on Jul 9, 2004 after an 81-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 21 later devices descend from it.
- Decided
- Jul 9, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
21 later devices descend from it, 1 citing it directly.
- This deviceK040999 Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)Procter & Gamble Co. · 2004
- Descendant · cites it directly · 20 of its ownK061486 Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies)Procter & Gamble Co. · 2006
- Descendant · 2 generations on · 17 of its ownK091084 Maxim Menstrual Tampons & Organyc Menstrual TamponsCotton High Tech S.L. · 2009
- Descendant · 2 generations on · 12 of its ownK080733 Cottons 100% Natural Cotton TamponsCottons Pty, Ltd. · 2009
- Descendant · 3 generations on · 11 of its ownK130609 Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013
- Descendant · 4 generations on · 9 of its ownK151170 Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K061486Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies)Procter & Gamble Co. · 2006 · cites it directly20descendants
- K091084Maxim Menstrual Tampons & Organyc Menstrual TamponsCotton High Tech S.L. · 2009 · 2 generations on17descendants
- K080733Cottons 100% Natural Cotton TamponsCottons Pty, Ltd. · 2009 · 2 generations on12descendants
- K130609Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013 · 3 generations on11descendants
- K151170Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K091084 | Maxim Menstrual Tampons & Organyc Menstrual Tampons | Cotton High Tech S.L. | 2009 | — |
| +2 | K080733 | Cottons 100% Natural Cotton Tampons | Cottons Pty, Ltd. | 2009 | — |
| +3 | K130609 | Veeda 100% Cotton Menstrual Tampon | Naturalena Brands, Inc. | 2013 | — |
| +4 | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K020096 | FDA’s K020096 is Esthetic Ease Abutments for the Iti Dental Implant System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061486 | Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies) | 2006 | 20 |
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?
- Of its descendants, K061486 (Procter & Gamble Co., 2006) has gone furthest, with 20 descendants of its own.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
TAMPAX" Tampons are unscented menstrual tampons that are inserted into the
vagina and used to absorb menstrual fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040999: Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040999
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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