510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3011 of 3529
510(k) clearances, page 3011 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K850217Cynomolgus Monkey Blood in Alsever'sHazleton Research Products, Inc.KITClass I
K850175Mentor Dbl-Coil Indwell. Silicone Ureteral Stent SMentorFADClass II
K844901Amer. Bentley Oxygenator Max-10 W/smooth Heat ExchAmerican BentleyDTZClass II
K850714C.a.d. Pack I -Arthroscopy Drape PackConcept, Inc.
K850645Intra-Arc Disposable Arthroplasty BurrsConcept, Inc.
K850596Pace*aid 10 a -Pad 10A- Pacemaker Output Display &Cardiac Resucitator Corp.DROClass II
K850576Pacesetter Sys, Endocardial, Ventricular, BipolarPacesetter SystemsDTDClass II
K850272Waters 740 Data Module-Plotter IntegratorEMD Millipore CorporationLDMClass I
K850240Km Products Suction TipsKm ProductsJOLClass II
K850051Versa-Fill 120 & Fill Set 42-50Intl. Medical IndustriesLHIClass II
K850049Katena Micrometer Knife W/xtal Blade of Crystal SaXtal Corp.HNNClass I
K844994The Mehesz Stimulating SystemCampden Medical, Ltd.GZJClass II
K844974Medtronic 5061 Endocardial Pacing LeadMedtronic, Inc.DTDClass II
K844915Imed 980 Volumetric Infusion PumpImed Corp.FRNClass II
K844693Peel-Away Introducer SetQuinton, Inc.DYBClass II
K844682Elecath Cardiac Output ComputerElectro-Catheter Corp.DXGClass II
K844104Cardio Analyzer Model 380Birtcher Corp.LOS
K850639Enzymatic Alpha-Amylase Reagent KitBio-Analytics Laboratories, Inc.CIWClass II
K850603Spq Test System for Alpha(2) MacroglobulinApplications LabDEBClass II
K850589Spq Test System for TransferrinApplications LabDDGClass II
K850588Spq Test System for Complement C3Applications LabCZWClass II
K850584Spq Test System for HaptoglobinApplications LabDADClass II
K850480Ovu Stick Self-Test -ModificationMonoclonal Antibodies, Inc.CEPClass I
K850458Dupont Digoxin Assay ReagentsE.I. Dupont de Nemours & Co., Inc.KXTClass II
K850457Du Pont Digoxin Assay CalibratorE.I. Dupont de Nemours & Co., Inc.DLJClass II
K850439Deseret Epidural CatheterParke-Davis Co.BSOClass II
K850364Glucose - Trinder- ReagentSigma Chemical Co.CGAClass II
K850359Waters 460 Liquid Chromatography Electrochemical DEMD Millipore CorporationLDMClass I
K850320Nebulizer Treatment KitDhd Medical Products Div. Diemolding Corp.
K850311Dispos. Conductive Adhesive TENS PadConsolidated Medical Equipment CompanyGXYClass II
K850298Ultralith Ultrasonic Lithotripsy SystemCabot Medical Corp.FEOClass II
K850257Bcs Glucose Colorimetric TestBioclinical Systems, Inc.CGAClass II
K850231Alpha Mem Medium W/o NucleosidesHazleton Research Products, Inc.
K850230Rpmi-1634 MediumHazleton Research Products, Inc.KITClass I
K850229Rpmi-1603 MediumHazleton Research Products, Inc.KITClass I
K850224Waymouth's Medium Mb 752/1Hazleton Research Products, Inc.KITClass I
K850222Hanks' Mem W/non-Essential Amino Acids Powder Med-Hazleton Research Products, Inc.KITClass I
K850221Alpha Mem W/nucleosides Powder MediumHazleton Research Products, Inc.KITClass I
K850213Isocontrol Serum Ck-MbSclavo, Inc.JJTClass I
K850143Spordex Culture MediaAmerican Sterilizer Co.JSCClass I
K850131Conductive Adhesive Post-Op Electrode-TENSConsolidated Medical Equipment CompanyGXYClass II
K850079Now Home Pregn. Test Kit Enzyme Immunoassay HcgBioclinical Systems, Inc.LCXClass II
K850052Anaerobe KitAustin Biological LaboratoriesJSPClass I
K850047Sanyo Electronic Muscle StimulatorsGeneral Physiotherapy, Inc.IPFClass II
K850017Precinorm H & Precipath HBoehringer Mannheim Corp.JJYClass I
K850003Coxsackie B Series Cf AntigensHillcrest BiologicalsGNGClass I
K845039Operaid Dispos. Irrigating KnifeJEDMED Instrument CompanyKYGClass I
K845008Bio-Bag Environmental Chamber -Type a-Multi-PlateMarion Laboratories, Inc.KZJClass I
K844967Echo Type 9 Cf AntigenHillcrest BiologicalsGNLClass I
K844965Leucine Aminopeptidase ReagentAlladin Diagnostic, Inc.JGGClass I