# K211519: Every Cycle Reusable Tampon Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Cycle, LLC
- Decided: Aug 13, 2021 after 88 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 K180850 (2018). 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)
- K180850: re.t.a Reuseable Tampon Applicator, Thinx, Inc. (2018) Summary page 5.

## Indications for use
Every Cycle™ Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.

Source page: https://510kreport.com/device/K211519
Methodology: https://510kreport.com/methodology