# K180167: Playtex Stella Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Playtex Manufacturing, Inc.
- Decided: May 30, 2018 after 128 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 K830966 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132819: Playtex (Scented and Unscented) Sport Fresh Balance Tampons, Playtex Manufacturing, Inc. (2013) Summary page 4.

## Indications for use
Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K180167
Methodology: https://510kreport.com/methodology