Sqa
FDA 510(k) K894949 · United Medical Systems, Inc.
510(k) numberK894949
Submission
- Device name
- Sqa
- Applicant
- United Medical Systems, Inc.
Washington, DC, US - Received
- August 3, 1989
- Decision date
- December 29, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K072538 | Piezolith 3000 Triple-Focus LithotripterLNS · Traditional | 01/30/2008SE |
| K032958 | Piezolith 3000 Lithotripter, Model 3000LNS · Traditional | 02/17/2004SE |
| K893003 | Tocolytic Site Care Sup Kit #1001/100A/CARRY CaseFOZ · Traditional | 07/14/1989SESD |
| K863645 | Schulman Double Umbilical Cord Clamp No. 1000HFW · Traditional | 09/25/1986SE |
Questions and answers
When was Sqa cleared by the FDA?
Sqa (K894949) received a 510(k) decision of Substantially Equivalent on December 29, 1989, 148 days after the submission was received.
What is the product code of K894949?
The FDA product code is POV – Semen Analysis Device, a Class II (moderate risk) device regulated under 21 CFR 864.5220.