510(k) · Cleared
ClearedOrganic Essentials, Organic Cotton Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organic Essentials · HEB Tampon, Menstrual, Unscented
Cleared on Nov 9, 1998 after a 38-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.
- Decided
- Nov 9, 1998
- Review
- 38 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK983478 Organic Essentials, Organic Cotton TamponOrganic Essentials · 1998
- Descendant · cites it directly · 14 of its ownK090098 Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009
- Descendant · 2 generations on · 13 of its ownK090819 Ontex Tampon (Unscented)Ontex International NV · 2009
- Descendant · 3 generations on · 8 of its ownK122603 Ontex and Other Proprietary NamesOntex Bvba · 2012
- Descendant · 4 generations on · 4 of its ownK142786 Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015
- Descendant · 5 generations on · 3 of its ownK232598 Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K090098Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009 · cites it directly14descendants
- K090819Ontex Tampon (Unscented)Ontex International NV · 2009 · 2 generations on13descendants
- K122603Ontex and Other Proprietary NamesOntex Bvba · 2012 · 3 generations on8descendants
- K142786Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015 · 4 generations on4descendants
- K232598Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983478 | Organic Essentials, Organic Cotton Tampon | Organic Essentials | 1998 | — |
| +1 | K090098 | Maxim Hygiene Organically Grown Cotton Tampon | Maxim Hygiene Products, Inc. | 2009 | — |
| +2 | K090819 | Ontex Tampon (Unscented) | Ontex International NV | 2009 | — |
| +3 | K122603 | Ontex and Other Proprietary Names | Ontex Bvba | 2012 | — |
| +4 | K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | 2015 | — |
| +5 | K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090098 | Maxim Hygiene Organically Grown Cotton Tampon | 2009 | 14 |
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, K090098 (Maxim Hygiene Products, Inc., 2009) has gone furthest, with 14 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?
The tampon is inserted into the vagina and absorbs menstrual fluid.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983478 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983478: Organic Essentials, Organic Cotton Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983478
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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