510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,732
176,529 records, page 1674 of 3531
510(k) clearances, page 1674 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K001241Evis Exera Colonovideoscope Cf-Q160 Al/i and Pcf-160 Al/iOlympus Optical Co., Ltd.FDFClass II
K001212Trojan Extra Large Latex CondomArmkel, LLCHISClass II
K001141Powder Free Sterile Latex Examination GlovesMedtronic, Inc.LYYClass I
K000755Rhigene Mesacup2 Test- SmRhigene, Inc.LKPClass II
K000752Rhigene Mesacup2 Test- RnpRhigene, Inc.LKOClass II
K000751Rhigene Mesacup2 Test- SsbRhigene, Inc.LLLClass II
K000750Rhigene Mesacup2 Test- Scl-70Rhigene, Inc.LLLClass II
K000749Rhigene Mesacup2 Test- SsaRhigene, Inc.LLLClass II
K000457Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000 SeriesRetinalabs.ComHMXClass I
K000451Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290Fresenius Medical Care Renal Therapies Group, LLCFJKClass II
K000328Medex 3000 Series MRI Compatible Syringe Infusion PumpMedex, Inc.FRNClass II
K000263Go Medical Balloon Infusion SystemGo Medical Industries Pty., Ltd.MEBClass II
K000216Psk Endoscope Cleaning SystemPsk Connectors Pty, Ltd.FEBClass II
K000420Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003Retinalabs.ComMRHClass II
K000416Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001Retinalabs.ComMPAClass II
K994433Connect Data Management SystemAbbott MedicalLFRClass II
K994243Directflow Kit, 24 Fr, Softclamp Kit, 24Fr, Straightshot Kit, 23 Fr, Straight Tip, Straightshot Kit, 23 Fr, Angled TipHeartport, Inc.DWFClass II
K993678Thrombelastograph Coagulation Analyzer Teg - 5000 SeriesHaemoscope Corp.JPAClass II
K991804Bindazyme Anti-B2 Screen Eia Test Kit.The Binding SiteMSVClass II
K991803Bindazyme Anti B2 Gp1 Igm Eia Test Kit.The Binding SiteMSVClass II
K991802Bindazyme Anti-B2 Gp1 Iga Eia Test KitThe Binding SiteMSVClass II
K991801Bindazyme Anti-B2 Gp1 Igg Eia Test KitThe Binding SiteMSVClass II
K991293Epstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable StimulatorFischer Medical Technologies, Inc.JOQClass II
K001310Vitros Chemistry Products Crea Slide, Virtros Chemistry Products Calibrator Kit 1Ortho-Clinical Diagnostics, Inc.JFYClass II
K001293Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached NeedleWest Pharma. Services IL, Ltd.LHIClass II
K001263Sharplan Lasers, Inc. Pulsed Cth:yag Holmium Surgical Laser, Model 2040E S C SharplanGEXClass II
K001144Ultraedge Keratome Blade, Model 374803 - AcsLasersight Technologies, Inc.HNOClass I
K001100Bioz.com Hemodynamic Monitor with Bioz Tect Sensor and Bioz Tect Cable Impedance PlethysmographCardiodynamics International Corp.DSBClass II
K000897Calibrite Percp-Cy5.5 Beads and Facscomp SoftwareBecton, Dickinson and Company, BD BiosciencesGKZClass II
K000734Pioneer Surgical Technology Extended Gtr, Model 501-601RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)KTTClass II
K000606Synchron Systems Amphetamine ReagentSiemens Healthcare Diagnostics Inc.DKZClass II
K000578Serim Leukocyte Esterase Test StripsSerim Research Corp.LJXClass I
K000577Yoshida Wave Pict Cam Intraoral Camera, Sigma Biomedics Sigmacam Intraoral CameraThe Yoshida Dental Mfg. Co., Ltd.EIAClass I
K000386Polygram 98 Anorectal Function Testing Application, Model 9043S0111Medtronic Functional Diagnostics A/SFFXClass II
K000248Carto Ep Navigation SystemBiosense Webster IncDQKClass II
K000190Modification to Carto Ep Navigation SystemBiosense Webster IncDQKClass II
K994126Modular-Plus Revision StemPlus OrthopedicsLWJClass II
K993841Cemstop Cement RestrictorEncore Orthopedics, Inc.LZNClass II
K993816Baxter Percutaneous Mechanical Thrombectomy (Pmt) Device, Models Pmt0606fd and Pmt1206fdBaxter EdwardsMCWClass II
K992592A-Miniature Centrifugal Blood Pump System, Model Cpb 2000A-Med Systems, Inc.KFMClass II
K991332Medi-Cult Sperm Preparation - Medium;Medicult A/SMQLClass II
K991327Medi-Cult Flushing MediumMedicult A/SMQLClass II
K980672Simplex Airbrator (Sab-7)Irt Management Corp.KOJClass II
K001248Multi-Pulse 2000Dental Imaging Technologies CorporationEHDClass II
K000940Human Serum Albumin (Hsa)Invitrocare IncMQLClass II
K000939Htf-HepesInvitrocare IncMQLClass II
K000816Sharp Brand Acupuncture NeedlesTcm Supply Corp.MQXClass II
K000805Kavo K.e.y. Laser 1242Kavo AmericaGEXClass II
K000783Direct Tibc CalibratorReference Diagnostics, Inc.JITClass II
K000691Vulcan Electrosurgical Probes: Vulcan Micro Ligament Chisels, Vulcan Ligament Chisels, Vulcan Eflex Ligament ChiselsOratec Interventions, Inc.HRXClass II