Béa Applicator (BAP-GB-01)
FDA 510(k) K242031 · Stepone Fertility Ltd (T/A Béa Fertility)
510(k) numberK242031
Submission
- Device name
- Béa Applicator (BAP-GB-01)
- Applicant
- Stepone Fertility Ltd (T/A Béa Fertility)
London, GB - Received
- July 11, 2024
- Decision date
- April 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HDR – Cap, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222969 | FERTI-LILY Conception CupHDR · Traditional | Rosesta Medical BV | 06/23/2023SE |
| K993953 | Oves Cervical CapHDR · Traditional | Veos , Ltd. | 03/21/2000SESU |
| K945131 | Imagyn Intrauterine Insemination DeviceHDR · Traditional | Imagyn Medical, Inc. | 05/15/1995SE |
| K950714 | Cook Insemination CupHDR · Traditional | Cook Urological, Inc. | 05/11/1995SE |
| K902171 | Minispace(Tm) Iui CatheterHDR · Traditional | Pharmacia, Inc. | 10/05/1990SE |
| K902694 | Coaxial Catheter SetHDR · Traditional | Cook Ob/Gyn | 08/28/1990SE |
| K896960 | Intrauterine Insemination CathetersHDR · Traditional | C.R. Bard, Inc. | 06/26/1990SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | Irvine Scientific | 04/16/1990SE |
| K900308 | Sperm Select SystemHDR · Traditional | Pharmacia, Inc. | 04/13/1990SE |
| K900162 | DGH A-San Probe HolderHDR · Traditional | Jedmed Instrument Co. | 02/16/1990SE |
Questions and answers
When was Béa Applicator (BAP-GB-01) cleared by the FDA?
Béa Applicator (BAP-GB-01) (K242031) received a 510(k) decision of Substantially Equivalent on April 2, 2025, 265 days after the submission was received.
What is the product code of K242031?
The FDA product code is HDR – Cap, Cervical, a Class II (moderate risk) device regulated under 21 CFR 884.5250.