# K830966: Playtex Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Playtex, Inc.
- Decided: Apr 8, 1983 after 11 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.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070745: Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons (2007), 6 descendants of its own
- K060981: Playtex Sport Plastic, Playtex Sport Plastic Multipack Tampons (2006), 3 descendants of its own
- K111684: Playtex Sport (Unscented) ,(Scented) with Odorshield (2012), 2 descendants of its own
- K132819: Playtex (Scented and Unscented) Sport Fresh Balance Tampons (2013), 1 descendant of its own
- K073662: Playtex Gentile Glide, Playtex Gentile Glide Multipack Tampons (2008), 1 descendant of its own

Source page: https://510kreport.com/device/K830966
Methodology: https://510kreport.com/methodology