# K230419: Sequel Tampon with Plastic Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Tampro, Inc.
- Decided: Aug 3, 2023 after 168 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: 2 generations back to K090071 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173225: Interlude and private label Unscented 3-piece compact applicator tampon, Albaad Fem (2018) Summary page 4.

## Indications for use
Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K230419
Methodology: https://510kreport.com/methodology