# K090098: Maxim Hygiene Organically Grown Cotton Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Maxim Hygiene Products, Inc.
- Decided: Jan 30, 2009 after 15 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 K914430 (1993). 2 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983478: Organic Essentials, Organic Cotton Tampon, Organic Essentials (1998) Summary page 1.
- K914430: Natracare Tampon, Bodywise (Uk), Ltd. (1993) Summary page 1.

## Most influential descendants
- K090819: Ontex Tampon (Unscented) (2009), 13 descendants of its own
- K122603: Ontex and Other Proprietary Names (2012), 8 descendants of its own
- K142786: Ontex Unscented Tampons with Colored Plastic Applicators (2015), 4 descendants of its own
- K232598: Unscented Menstrual Tampon (2023), 3 descendants of its own
- K251033: Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons (2025), 1 descendant of its own

## Indications for use
Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

Source page: https://510kreport.com/device/K090098
Methodology: https://510kreport.com/methodology