510(k) · Cleared
Recalled · 2011Kotex Security Tampons (Several Type)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · HEB Tampon, Menstrual, Unscented
Cleared on Dec 22, 1989 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 1989
- Review
- 11 days
- Class
- Class II
- Product code
- HEB
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK896994 Kotex Security Tampons (Several Type)Kimberly-Clark Corp. · 1989
- Descendant · cites it directly · 1 of its ownK023479 Femtex Tampons and Other Private Label Plastic Applicator Tampons…First Quality Hygienic, Inc. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK141294 U by Kotex Security Unscented Menstrual TamponsKimberly-Clark Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK050660 Femtex and Private Label Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K023479Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and…First Quality Hygienic, Inc. · 2002 · cites it directly1descendant
- K141294U by Kotex Security Unscented Menstrual TamponsKimberly-Clark Corp. · 2014 · cites it directly0descendants
- K050660Femtex and Private Label Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896994 | Kotex Security Tampons (Several Type) | Kimberly-Clark Corp. | 1989 | — |
| +1 | K023479 | Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer… | First Quality Hygienic, Inc. | 2002 | 1 |
| +1 | K141294 | U by Kotex Security Unscented Menstrual Tampons | Kimberly-Clark Corp. | 2014 | — |
| +2 | K050660 | Femtex and Private Label Plastic Applicator Tampons | First Quality Hygienic, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 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? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2011 | Not classified | Z-0393-2012 | Material/Component Contamination | A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023479 (First Quality Hygienic, Inc., 2002) has gone furthest, with 1 descendant 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/K896994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K896994: Kotex Security Tampons (Several Type).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896994
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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