# K141294: U by Kotex Security Unscented Menstrual Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Aug 25, 2014 after 98 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896994 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896994: Kotex Security Tampons (Several Type), Kimberly-Clark Corp. (1989) Summary page 4.

## Indications for use
Kimberly-Clark* U by Kotex® Security® is an unscented menstrual tampon intended to be inserted into the vagina to absorb menstrual fluid.

Source page: https://510kreport.com/device/K141294
Methodology: https://510kreport.com/methodology