# K181911: Interlude 100% Cotton Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Albaad Fem
- Decided: Nov 2, 2018 after 108 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 K001641 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001641: Tampons, Rostam, Ltd. (2000) Summary page 4.

## Indications for use
Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.

Source page: https://510kreport.com/device/K181911
Methodology: https://510kreport.com/methodology