Sqa V, Sperm Quality Analyzer
FDA 510(k) K021746 · Medical Electronic Systems, LLC
510(k) numberK021746
Submission
- Device name
- Sqa V, Sperm Quality Analyzer
- Applicant
- Medical Electronic Systems, LLC
Beverly Hills, CA, US - Received
- May 28, 2002
- Decision date
- September 20, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K243114 | SQA-iOw Sperm Quality AnalyzerPOV · Dual Track | 05/02/2025SE |
| K241628 | YO Home Sperm TestPOV · Traditional | 11/29/2024SE |
| 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 |
| K012352 | Sqa, Sperm Quality AnalyzerPOV · Traditional | 09/21/2001SE |
Questions and answers
When was Sqa V, Sperm Quality Analyzer cleared by the FDA?
Sqa V, Sperm Quality Analyzer (K021746) received a 510(k) decision of Substantially Equivalent on September 20, 2002, 115 days after the submission was received.
What is the product code of K021746?
The FDA product code is POV – Semen Analysis Device, a Class II (moderate risk) device regulated under 21 CFR 864.5220.