Trak Male Fertility Testing System
FDA 510(k) K153683 · Sandstone Diagnostics, Inc.
510(k) numberK153683
Submission
- Device name
- Trak Male Fertility Testing System
- Applicant
- Sandstone Diagnostics, Inc.
Livermore, CA, US - Received
- December 22, 2015
- Decision date
- May 16, 2016
- 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 |
| 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 |
More from Sandstone Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172514 | Trak Plus Male Fertility Testing SystemPOV · Traditional | 11/17/2017SE |
Questions and answers
When was Trak Male Fertility Testing System cleared by the FDA?
Trak Male Fertility Testing System (K153683) received a 510(k) decision of Substantially Equivalent on May 16, 2016, 146 days after the submission was received.
What is the product code of K153683?
The FDA product code is POV – Semen Analysis Device, a Class II (moderate risk) device regulated under 21 CFR 864.5220.