# K223883: Daye Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Annes Daye, Ltd.
- Decided: Aug 18, 2023 after 234 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: 4 generations back to K914430 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162746: Ontex and other proprietary names, Ontex Bvba (2017) Summary page 4.

## Indications for use
The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.

Source page: https://510kreport.com/device/K223883
Methodology: https://510kreport.com/methodology