# K080775: Maxim Plastic Applicator & Non-Applicator Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Tosama D.D.
- Decided: Sep 10, 2008 after 175 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tampax Compak, Compact Plastic Appli. Super Tampo: named in the summary without a submission number
- (no number) o.b.® Non-applicator Tampons: named in the summary without a submission number

## Most influential descendants
- 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 (2015), 2 descendants of its own
- 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
- K120481: Lil-Lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super Plus and Ultra Lil-Lets Non Applicator, (2012), 0 descendants of its own
- K092054: Moxie Plastic Applicator and Moxie Non-Applicator Tampon (2009), 0 descendants of its own

## Indications for use
The MAXIM tampons (both types) are unscented tampons for: • Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal disctlarge. • The plastic applicator is for easing the placement of the tampon correctly into the vagina (only the MAXIM Plastic Applicator Tampon).

Source page: https://510kreport.com/device/K080775
Methodology: https://510kreport.com/methodology