510(k) · Cleared
ClearedNatracaren Applicator Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodywise (Uk), Ltd. · HEB Tampon, Menstrual, Unscented
Cleared on Jan 25, 1996 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Jan 25, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK954942 Natracaren Applicator TamponBodywise (Uk), Ltd. · 1996
- Descendant · cites it directly · 17 of its ownK091084 Maxim Menstrual Tampons & Organyc Menstrual TamponsCotton High Tech S.L. · 2009
- Descendant · 2 generations on · 11 of its ownK130609 Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013
- Descendant · 3 generations on · 9 of its ownK151170 Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015
- Descendant · 4 generations on · 3 of its ownK231341 Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK152284 Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact…Cotton High Tech S.L. · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K091084Maxim Menstrual Tampons & Organyc Menstrual TamponsCotton High Tech S.L. · 2009 · cites it directly17descendants
- K130609Veeda 100% Cotton Menstrual TamponNaturalena Brands, Inc. · 2013 · 2 generations on11descendants
- K151170Tosama 100% Organic Cotton Menstrual TamponTosama, D.O.O. · 2015 · 3 generations on9descendants
- K231341Organic cotton tampon, Viscose tamponZhejiang Tianqing Manufacturing Technology Group Co., Ltd. · 2023 · 4 generations on3descendants
- K152284Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic…Cotton High Tech S.L. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954942 | Natracaren Applicator Tampon | Bodywise (Uk), Ltd. | 1996 | — |
| +1 | K091084 | Maxim Menstrual Tampons & Organyc Menstrual Tampons | Cotton High Tech S.L. | 2009 | — |
| +2 | K130609 | Veeda 100% Cotton Menstrual Tampon | Naturalena Brands, Inc. | 2013 | — |
| +3 | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015 | — |
| +4 | K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023 | — |
| +2 | K152284 | Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator… | Cotton High Tech S.L. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091084 | Maxim Menstrual Tampons & Organyc Menstrual Tampons | 2009 | 17 |
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, K091084 (Cotton High Tech S.L., 2009) has gone furthest, with 17 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 | — |
https://510kreport.com/device/K954942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954942: Natracaren Applicator Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954942
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026