K242031 is an FDA 510(k) clearance for the B?a Applicator (BAP-GB-01). This device is classified as a Cap, Cervical (Class II — Special Controls, product code HDR).
Submitted by Stepone Fertility Ltd (T/A B?a Fertility) (London, GB). The FDA issued a Cleared decision on April 2, 2025, 265 days after receiving the submission on July 11, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K242031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2024 |
| Decision Date | April 02, 2025 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDR — Cap, Cervical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5250 |