# K132819: Playtex (Scented and Unscented) Sport Fresh Balance Tampons

- Pathway: 510(k) (Special)
- Applicant: Playtex Manufacturing, Inc.
- Decided: Oct 9, 2013 after 30 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
Longest line of descent: 3 generations back to K830966 (1983). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K111684: Playtex Sport (Unscented) ,(Scented) with Odorshield, Playtex Manufacturing, Inc. (2012) Summary page 1.

## Most influential descendants
- K180167: Playtex Stella Tampons (2018), 0 descendants of its own

## Indications for use
Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid. Absorbs menstrual flow < 6 grams (Light) Absorbs menstrual flow 6-9 gram (Regular) Absorbs menstrual flow 9-12 grams (Super) Absorbs menstrual flow 12-15 grams (Super Plus)

Source page: https://510kreport.com/device/K132819
Methodology: https://510kreport.com/methodology