# K222969: FERTI-LILY Conception Cup

- Pathway: 510(k) (Traditional)
- Applicant: Rosesta Medical BV
- Decided: Jun 23, 2023 after 269 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: 1 generation back to K993953 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993953: Oves Cervical Cap, Veos, Ltd. (2000) Summary page 4.

## Most influential descendants
- K242031: Béa Applicator  (BAP-GB-01) (2025), 0 descendants of its own

## Indications for use
The FERTI.LILY Conception Cup is indicated for over-the-counter home use. It is for couples who have been unable to conceive naturally and who have received a diagnosis of low sperm count, sperm immobility or unfavorable vaginal environment. After intercourse, the FERTI.LILY Conception Cup is placed around the cervix. It retains semen near the cervical os (the passage between the vaginal cavity and the uterus) as an aid to conception. The FERTI.LILY Conception Cup should be used during the ovulatory phase of the menstrual cycle. The FERTI.LILY Conception Cup should not be left in place for longer than one hour.

Source page: https://510kreport.com/device/K222969
Methodology: https://510kreport.com/methodology