# K011996: Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus

- Pathway: 510(k) (Traditional)
- Applicant: Procter & Gamble Co.
- Decided: Sep 19, 2001 after 84 days
- Product code: HIL ( Tampon, Menstrual, Scented, Scented-Deodorized)
- Device class: 2
- Regulation: 21 CFR 884.5460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K040312: Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus (2004), 6 descendants of its own
- K051290: Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented) (2005), 5 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K011996
Methodology: https://510kreport.com/methodology