510(k) · Cleared
ClearedFERTI-LILY Conception Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rosesta Medical BV · HDR Cap, Cervical
Cleared on Jun 23, 2023 as substantially equivalent to K993953 (Veos, Ltd., 2000) after a 269-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jun 23, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- HDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993953 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K242031Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility) · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993953 | Oves Cervical Cap | Veos, Ltd. | 2000 | — |
| 0 (this device) | K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | 2023 | — |
| +1 | K242031 | Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HDR device
- #1 K242031 Béa Applicator (BAP-GB-01)score 9.4 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993953 | Oves Cervical CapSummary page 4…atory Class: Class II 5. Predicate Device Information Device Name: Oves Cervical Cap 510(k) Number: K993953 Sponsor: Veos Ltd. The predicate device has not been subject to a design-related recall. 6. De… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242031 | Béa Applicator (BAP-GB-01) | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HDR devicesHDR Cap, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HDR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HDR
Too few HDR 510(k)s in any year since 2007 to give a median.
Recalls per year · HDR
No recall names HDR since 2007.
Adverse event reports per year · HDR
1in 2014
MAUDE reports naming product code HDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222969: FERTI-LILY Conception Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222969
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026