# K081555: Tampax Pearl Plastic Applicator Tampons, Scented and Unscented

- Pathway: 510(k) (Special)
- Applicant: Procter & Gamble Co.
- Decided: Jun 27, 2008 after 24 days
- Product code: HIL ( Tampon, Menstrual, Scented, Scented-Deodorized)
- Device class: 2
- Regulation: 21 CFR 884.5460
- Recalls of this device: 1 (0 Class I)
- 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.
3 later devices descend from it; 3 cite it directly.
0 of 7 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.
- K051290: Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented), Procter & Gamble Co. (2005) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Dec 26, 2025 · Class II · Z-1182-2026: Potential exposure of rodents and rodent activity in the distribution center.

## Indications for use
The TAMPAX ® Pearl Plastic unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.

Source page: https://510kreport.com/device/K081555
Methodology: https://510kreport.com/methodology