510(k) · Cleared
ClearedMaxim Hygiene Organically Grown Cotton Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxim Hygiene Products, Inc. · HEB Tampon, Menstrual, Unscented
Cleared on Jan 30, 2009 as substantially equivalent to K983478 (Organic Essentials, 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1993. 14 later devices descend from it.
- Decided
- Jan 30, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914430 (1993). 2 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914430 Natracare TamponBodywise (Uk), Ltd. · 1993
- This deviceK090098 Maxim Hygiene Organically Grown Cotton TamponMaxim Hygiene Products, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK090819 Ontex Tampon (Unscented)Ontex International NV · 2009
- Descendant · 2 generations on · 8 of its ownK122603 Ontex and Other Proprietary NamesOntex Bvba · 2012
- Descendant · 3 generations on · 4 of its ownK142786 Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015
- Descendant · 4 generations on · 3 of its ownK232598 Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023
- Descendant · 5 generations on · 1 of its ownK251033 Unscented menstrual long applicator tampon; Unscented menstrual…Unibeauty (Hubei) Technology Co., Ltd. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K090819Ontex Tampon (Unscented)Ontex International NV · 2009 · cites it directly13descendants
- K122603Ontex and Other Proprietary NamesOntex Bvba · 2012 · 2 generations on8descendants
- K142786Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba · 2015 · 3 generations on4descendants
- K232598Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd. · 2023 · 4 generations on3descendants
- K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…Unibeauty (Hubei) Technology Co., Ltd. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914430 | Natracare Tampon | Bodywise (Uk), Ltd. | 1993 | — |
| 0 (this device) | K090098 | Maxim Hygiene Organically Grown Cotton Tampon | Maxim Hygiene Products, Inc. | 2009 | — |
| +1 | K090819 | Ontex Tampon (Unscented) | Ontex International NV | 2009 | — |
| +2 | K122603 | Ontex and Other Proprietary Names | Ontex Bvba | 2012 | — |
| +3 | K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | 2015 | — |
| +4 | K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023 | — |
| +5 | K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact… | Unibeauty (Hubei) Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 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 |
|---|---|---|---|
| * | K983478 | Organic Essentials, Organic Cotton TamponSummary page 1…Tampon Regulation Number: 21 CFR 884.5470 Product Code: HEB Predicate Device(s): K983478 Organic Essentials Organic Cotton Tampon K914430… | 1998 |
| * | K914430 | Natracare TamponSummary page 1…HEB Predicate Device(s): K983478 Organic Essentials Organic Cotton Tampon K914430 Natracare Tampon 11.0 Intended Use: Maxim Hygiene Organically Grown Cotton Tampon is a tam… | 1993 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090819 | Ontex Tampon (Unscented) | 2009 | 13 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K090819 (Ontex International NV, 2009) has gone furthest, with 13 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. 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?
Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid.
The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090098: Maxim Hygiene Organically Grown 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/K090098
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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