# K133244: Tampax M Plastic Tampons, Unscented

- Pathway: 510(k) (Special)
- Applicant: The Procter & Gamble Company
- Decided: Jan 9, 2014 after 79 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: 4 generations back to K011996 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081555: Tampax Pearl Plastic Applicator Tampons, Scented and Unscented, Procter & Gamble Co. (2008) Summary page 1.

## Indications for use
The TAMPAX M Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.

Source page: https://510kreport.com/device/K133244
Methodology: https://510kreport.com/methodology