# K051290: Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)

- Pathway: 510(k) (Traditional)
- Applicant: Procter & Gamble Co.
- Decided: Dec 27, 2005 after 223 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 K011996 (2001). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 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) Summary page 1.
- K040312: Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus, Procter & Gamble Co. (2004) Summary page 1.

## Most influential descendants
- K081555: Tampax Pearl Plastic Applicator Tampons, Scented and Unscented (2008), 3 descendants of its own
- K133244: Tampax M Plastic Tampons, Unscented (2014), 0 descendants of its own
- K131543: Tampax (R) L Plastic Tampons, Unscented (2013), 0 descendants of its own
- K110669: Tampax C Plastic Tampons, Unscented (2011), 0 descendants of its own
- K091281: Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl Unscented Tampons, Ultra (2010), 0 descendants of its own

## Indications for use
TAMPAX® Pearl Plastic Applicator Tampons, Ultra Absorbency (unscented and scented) are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid on day(s) of heaviest menstrual flow. Ultra absorbency should not be used on days of light or moderate flow.

Source page: https://510kreport.com/device/K051290
Methodology: https://510kreport.com/methodology