# K191431: Interlude Rolled Tampons in Plastic Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Albaad Fem
- Decided: Oct 7, 2019 after 131 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
Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K191431
Methodology: https://510kreport.com/methodology