Product code POV
- Product
- Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical De
- Definition
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
- Description
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
- Regulation number
- Radiation type
- Radiation Emitting Electronic Product Codes // Qui
- Applicable standards
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Current FDA Classification
- Device name
- Semen Analysis Device
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5220
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- 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.
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252228 | Seaman Pro/Seaman | Checkcells, Inc. | 2026-04-09 |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2025-05-30 |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | 2025-05-09 |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2025-05-02 |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2024-11-29 |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | 2023-08-07 |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | 2020-10-28 |
| K183602 | SwimCount Sperm Quality Test | Motilitycount Aps | 2019-06-27 |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | 2018-11-16 |
| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2017-11-17 |
| K161493 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | 2016-11-08 |
| K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | 2016-05-16 |
| K100341 | SPERMCHECK FERTILITY | Princeton BioMeditech Corp. | 2010-05-04 |
| K073039 | SPERMCHECK VASECTOMY | Princeton BioMeditech Corp. | 2008-01-24 |
| K071737 | GENERAL SEMEN ANALYSIS KIT | Dyn-Bioshaf (2006) , Ltd. | 2007-10-25 |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | Medical Electronic Systems , Ltd. | 2007-03-26 |
| K041039 | FERTELL MALE FERTILITY TEST | Genosis , Ltd. | 2004-07-20 |
| K032874 | HBA SPERM-HYALURONAN BINDING ASSAY | Biocoat, Inc. | 2003-11-24 |
| K024337 | GENERAL SEMEN ANALYSIS (GSA) KIT | Bioshaf , Ltd. | 2003-07-03 |
| K021746 | SQA V, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | 2002-09-20 |
| K012805 | AUTOMARQER | Hamilton Thorne Research | 2002-03-13 |
| K012352 | SQA, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | 2001-09-21 |
| K011679 | FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY | Embryotech Laboratories, Inc. | 2001-08-15 |
| K990184 | AUTOMARQER | Hamilton Thorne Research | 1999-03-19 |
| K983473 | FERTILMARQ TEST KIT | Embryotech Laboratories, Inc. | 1998-12-17 |
| K915229 | SEMEN ANALYSIS KIT | Humagen Fertility Diagnostics, Inc. | 1994-08-30 |
| K894949 | SQA | United Medical Systems, Inc. | 1989-12-29 |
| K881765 | CTS-3060 AUTOMATED SEMEN ANALYZER | Motion Analysis Corp. | 1989-02-15 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00859500005318 | FemSperm Pack Analysis | FEMASYS INC. | 2026-02-06 |
| 00859500005349 | FemSperm Pack Analysis | FEMASYS INC. | 2026-02-06 |
| 14719874743502 | LensHooke Semen Test Slide | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743519 | LensHooke Semen Test Slide | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743526 | LensHooke Sperm Double Strand DNA fragmentation Rapid Test Kit (SDFR Assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743533 | LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 14719874743571 | LensHooke Sperm DNA fragmentation rapid test kit (SCD assay) | BONRAYBIO CO., LTD. | 2026-02-06 |
| 00859500005288 | FemSperm Analyzer | FEMASYS INC. | 2026-02-06 |
| 14719874743458 | LensHooke Semen Analysis System | BONRAYBIO CO., LTD. | 2025-09-01 |
| 14719874743465 | LensHooke Semen Analysis System | BONRAYBIO CO., LTD. | 2025-09-01 |
| 07290016650822 | SQA-iOw Sperm Quality Analyzer | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2025-05-21 |
| 14719874743076 | LensHooke Cleaning Wipe | BONRAYBIO CO., LTD. | 2025-02-16 |
| 14719874743069 | LensHooke Cleaning Wipe | BONRAYBIO CO., LTD. | 2025-02-16 |
| 14719874740747 | LensHooke Cleaning Wipe | BONRAYBIO CO., LTD. | 2025-02-16 |
| 04719874741303 | LensHooke Semen Quality Analyzer | BONRAYBIO CO., LTD. | 2025-02-16 |
| 14719874740808 | LensHooke Cleaning Wipe | BONRAYBIO CO., LTD. | 2025-02-16 |
| 04719874741297 | LensHooke Semen Quality Analyzer | BONRAYBIO CO., LTD. | 2025-02-13 |
| 00843277100048 | SwimCount Sperm Quality Test | Motilitycount ApS | 2024-06-17 |
| 07290016650402 | SQA-iO Sperm Quality Analyzer | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2023-09-06 |
| 00860001286533 | Men's Rapid Fertility Test | MEDTOX DIAGNOSTICS, INC. | 2022-07-26 |
| 00862105000398 | Trak | MEDTOX DIAGNOSTICS, INC. | 2022-07-05 |
| 00862105000305 | Men's Rapid Fertility Test | MEDTOX DIAGNOSTICS, INC. | 2022-06-13 |
| 00862105000312 | Men's Rapid Fertility Test | MEDTOX DIAGNOSTICS, INC. | 2022-06-13 |
| 04719874741570 | LensHooke Semen Quality Analyzer | BONRAYBIO CO., LTD. | 2021-08-26 |
| 44719874740717 | LensHooke semen Test Cassette | BONRAYBIO CO., LTD. | 2021-07-09 |
| 44719874740762 | LensHooke semen Test Cassette | BONRAYBIO CO., LTD. | 2021-07-09 |
| 44719874741141 | LensHooke semen Test Cassette | BONRAYBIO CO., LTD. | 2021-07-09 |
| 44719874741158 | LensHooke semen Test Cassette | BONRAYBIO CO., LTD. | 2021-07-09 |
| 54719874740714 | LensHooke semen Test Cassette | BONRAYBIO CO., LTD. | 2021-07-09 |
| 04719874740702 | LensHooke Semen Quality Analyzer | BONRAYBIO CO., LTD. | 2019-10-07 |