# K091281: Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl Unscented Tampons, Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Procter & Gamble Co.
- Decided: Jun 1, 2010 after 396 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: 3 generations back to K011996 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011996: Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus, Procter & Gamble Co. (2001)
- K051290: Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented), Procter & Gamble Co. (2005)

## Indications for use
TAMPAX® Pearl Plastic Applicator Unscented Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K091281
Methodology: https://510kreport.com/methodology