# K151470: Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency

- Pathway: 510(k) (Abbreviated)
- Applicant: First Quality Hygienic, Inc.
- Decided: Nov 2, 2015 after 154 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: 1 generation back to K080775 (2008). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080775: Maxim Plastic Applicator & Non-Applicator Tampons, Tosama D.D. (2008) Summary page 4.

## Most influential descendants
- K182142: FEMME Applicator Tampon (2019), 0 descendants of its own
- K161877: Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl (2016), 0 descendants of its own

## Indications for use
Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.

Source page: https://510kreport.com/device/K151470
Methodology: https://510kreport.com/methodology