SwimCount Sperm Quality Test
FDA 510(k) K183602 · Motilitycount Aps
510(k) numberK183602
Submission
- Device name
- SwimCount Sperm Quality Test
- Applicant
- Motilitycount Aps
Valby, DK - Received
- December 26, 2018
- Decision date
- June 27, 2019
- 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 |
| K241628 | YO Home Sperm TestPOV · Traditional | Medical Electronic Systems , Ltd. | 11/29/2024SE |
| 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 |
| 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 |
|---|---|---|
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)MQK · Traditional | 01/31/2025SE |
Questions and answers
When was SwimCount Sperm Quality Test cleared by the FDA?
SwimCount Sperm Quality Test (K183602) received a 510(k) decision of Substantially Equivalent on June 27, 2019, 183 days after the submission was received.
What is the product code of K183602?
The FDA product code is POV – Semen Analysis Device, a Class II (moderate risk) device regulated under 21 CFR 864.5220.