# K896994: Kotex Security Tampons (Several Type)

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Dec 22, 1989 after 11 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023479: Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages (2002), 1 descendant of its own
- K141294: U by Kotex Security Unscented Menstrual Tampons (2014), 0 descendants of its own
- K050660: Femtex and Private Label Plastic Applicator Tampons (2005), 0 descendants of its own

## Recalls of this device
- Nov 3, 2011 · Not classified · Z-0393-2012: 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 

Source page: https://510kreport.com/device/K896994
Methodology: https://510kreport.com/methodology