Data / Medical devices / United States / Premier Sperm Donors LLC
Premier Sperm Donors LLC: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance
Premier Sperm Donors LLC is registered with the FDA (registration 3030595020) in Austin, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030595020
- Address
- 1611 Cloverleaf Dr, Austin, TX, United States, 78723
- Owner or operator
- Premier Sperm Donors (10094644)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 12, 2025
- Registered through
- 2026
- Brand names listed
- Mosie Baby
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| At Home Intravaginal Insemination System | QYZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2023 | K231203 | Mosie Baby Kit | QYZ | Substantially Equivalent | Mosie Baby | accessdata.fda.gov |
Compare with other makers
Updated November 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.