Panels › Hematology › Product code POV · Class 2
Semen Analysis Device
Regulation 864.5220
1510(k)s in 12 months (28 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in POV
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Electronic Systems , Ltd. | 7 | 0 |
| Bonraybio Co., Ltd. | 4 | 0 |
| Embryotech Laboratories, Inc. | 2 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 2 |
| Hamilton Thorne Research | 2 | 0 |
| Princeton BioMeditech Corp. | 2 | 0 |
| Sandstone Diagnostics, Inc. | 2 | 0 |
| Biocoat, Inc. | 1 | 0 |
| Bioshaf , Ltd. | 1 | 0 |
| Checkcells, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2026 | K252228 | Seaman Pro/Seaman Checkcells, Inc. | POV |
| May 30, 2025 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer Bonraybio Co., Ltd., TW | POV |
| May 9, 2025 | K242388 | LensHooke X12 PRO Semen Analysis System Bonraybio Co., Ltd., TW | POV |
| May 2, 2025 | K243114 | SQA-iOw Sperm Quality Analyzer Medical Electronic Systems , Ltd., IL | POV |
| Nov 29, 2024 | K241628 | YO Home Sperm Test Medical Electronic Systems , Ltd., IL | POV |
| Aug 7, 2023 | K220828 | SQA-iO Sperm Quality Analyzer Medical Electronic Systems , Ltd., IL | POV |
| Oct 28, 2020 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer Bonraybio Co., Ltd., TW | POV |
| Jun 27, 2019 | K183602 | SwimCount Sperm Quality Test Motilitycount Aps, DK | POV |
| Nov 16, 2018 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd., TW | POV |
| Nov 17, 2017 | K172514 | Trak Plus Male Fertility Testing System Sandstone Diagnostics, Inc. | POV |
| Nov 8, 2016 | K161493 | YO Home Sperm Test Medical Electronic Systems , Ltd., IL | POV |
| May 16, 2016 | K153683 | Trak Male Fertility Testing System Sandstone Diagnostics, Inc. | POV |
| May 4, 2010 | K100341 | SPERMCHECK FERTILITY Princeton BioMeditech Corp. | POV |
| Jan 24, 2008 | K073039 | SPERMCHECK VASECTOMY Princeton BioMeditech Corp. | POV |
| Oct 25, 2007 | K071737 | GENERAL SEMEN ANALYSIS KIT Dyn-Bioshaf (2006) , Ltd. | POV |
| Mar 26, 2007 | K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS Medical Electronic Systems , Ltd. | POV |
| Jul 20, 2004 | K041039 | FERTELL MALE FERTILITY TEST Genosis , Ltd. | POV |
| Nov 24, 2003 | K032874 | HBA SPERM-HYALURONAN BINDING ASSAY Biocoat, Inc. | POV |
| Jul 3, 2003 | K024337 | GENERAL SEMEN ANALYSIS (GSA) KIT Bioshaf , Ltd. | POV |
| Sep 20, 2002 | K021746 | SQA V, SPERM QUALITY ANALYZER Medical Electronic Systems, LLC | POV |
| Mar 13, 2002 | K012805 | AUTOMARQER Hamilton Thorne Research | POV |
| Sep 21, 2001 | K012352 | SQA, SPERM QUALITY ANALYZER Medical Electronic Systems, LLC | POV |
| Aug 15, 2001 | K011679 | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY Embryotech Laboratories, Inc. | POV |
| Mar 19, 1999 | K990184 | AUTOMARQER Hamilton Thorne Research | POV |
| Dec 17, 1998 | K983473 | FERTILMARQ TEST KIT Embryotech Laboratories, Inc. | POV |
| Aug 30, 1994 | K915229 | SEMEN ANALYSIS KIT Humagen Fertility Diagnostics, Inc. | POV |
| Dec 29, 1989 | K894949 | SQA United Medical Systems, Inc. | POV |
| Feb 15, 1989 | K881765 | CTS-3060 AUTOMATED SEMEN ANALYZER Motion Analysis Corp. | POV |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.