# K242031: Béa Applicator  (BAP-GB-01)

- Pathway: 510(k) (Traditional)
- Applicant: Stepone Fertility Ltd (T/A Béa Fertility)
- Decided: Apr 2, 2025 after 265 days
- Product code: HDR (Cap, Cervical)
- Device class: 2
- Regulation: 21 CFR 884.5250
- 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 K993953 (2000). 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)
- K222969: FERTI-LILY Conception Cup, Rosesta Medical BV (2023) Summary page 5.

## Indications for use
The Béa Applicator is indicated for over-the-counter home use by couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. The Béa Applicator contains a Béa Cervical Cap which is used to contain, deliver, and retain semen near the cervical opening as an aid to conception. The Béa Applicator should be used during the ovulatory phase of the menstrual cycle. The Béa Cervical Cap should not be left in place for longer than 5 hours.

Source page: https://510kreport.com/device/K242031
Methodology: https://510kreport.com/methodology