# K103311: U by Kotex Click Unscented Menstrul Tampons

- Pathway: 510(k) (Special)
- Applicant: Kimberly Clark Corporation
- Decided: Dec 10, 2010 after 30 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: 2 generations back to K864750 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091749: U by Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super and Super Plus, Kimberly-Clark Corp. (2009) Summary page 1.

## Indications for use
Kimberly-Crark* U by KOTEX Click t is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.

Source page: https://510kreport.com/device/K103311
Methodology: https://510kreport.com/methodology