YO Home Sperm Test
FDA 510(k) K241628 · Medical Electronic Systems , Ltd.
510(k) numberK241628
Submission
- Device name
- YO Home Sperm Test
- Applicant
- Medical Electronic Systems , Ltd.
Caesarea, IL - Received
- June 6, 2024
- Decision date
- November 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- POV – Semen Analysis Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.
Other 510(k)s with product code POV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252228 | Seaman Pro/SeamanPOV · Traditional | Checkcells, Inc. | 04/09/2026SE |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerPOV · Traditional | Bonraybio Co., Ltd. | 05/30/2025SE |
| K242388 | LensHooke X12 PRO Semen Analysis SystemPOV · Traditional | Bonraybio Co., Ltd. | 05/09/2025SE |
| K243114 | SQA-iOw Sperm Quality AnalyzerPOV · Dual Track | Medical Electronic Systems , Ltd. | 05/02/2025SE |
| K220828 | SQA-iO Sperm Quality AnalyzerPOV · Traditional | Medical Electronic Systems , Ltd. | 08/07/2023SE |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOV · Special | Bonraybio Co., Ltd. | 10/28/2020SE |
| K183602 | SwimCount Sperm Quality TestPOV · Traditional | Motilitycount Aps | 06/27/2019SE |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerPOV · Traditional | Bonraybio Co., Ltd. | 11/16/2018SE |
| K172514 | Trak Plus Male Fertility Testing SystemPOV · Traditional | Sandstone Diagnostics, Inc. | 11/17/2017SE |
| K161493 | YO Home Sperm TestPOV · Traditional | Medical Electronic Systems , Ltd. | 11/08/2016SE |
More from Medical Electronic Systems , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243114 | SQA-iOw Sperm Quality AnalyzerPOV · Dual Track | 05/02/2025SE |
| K220828 | SQA-iO Sperm Quality AnalyzerPOV · Traditional | 08/07/2023SE |
| K161493 | YO Home Sperm TestPOV · Traditional | 11/08/2016SE |
| K063864 | Qwikcheck Test Strips- Reagent Strips for Semen AnalysisPOV · Traditional | 03/26/2007SE |
| K021746 | Sqa V, Sperm Quality AnalyzerPOV · Traditional | 09/20/2002SE |
| K012352 | Sqa, Sperm Quality AnalyzerPOV · Traditional | 09/21/2001SE |
Questions and answers
When was YO Home Sperm Test cleared by the FDA?
YO Home Sperm Test (K241628) received a 510(k) decision of Substantially Equivalent on November 29, 2024, 176 days after the submission was received.
What is the product code of K241628?
The FDA product code is POV – Semen Analysis Device, a Class II (moderate risk) device regulated under 21 CFR 864.5220.