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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
45,969 of the 176,366 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
20262,569
176,366 records, page 3150 of 3528
510(k) clearances, page 3150 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K831685Sf Refeeding MediaViromed Laboratories, Inc.KITClass I
K831684Cynomolgus Monkey Kidney Cells Sv5Viromed Laboratories, Inc.KIRClass I
K831683Sf CellsViromed Laboratories, Inc.KIRClass I
K831682Mccoy CellsViromed Laboratories, Inc.KIRClass I
K831681Hep-2 CellsViromed Laboratories, Inc.KIRClass I
K831680Vero CellsViromed Laboratories, Inc.KIRClass I
K831679Mrc-5 CellsViromed Laboratories, Inc.KIRClass I
K831628Creatinine Reagents B6370-13American Scientific ProductsCGXClass II
K831627Creatinine Reagents B6360-10American Scientific ProductsCGXClass II
K831624Glucose Reagent Kits-B6370-10AAmerican Scientific ProductsCGAClass II
K831560Glucose Hexokinase Diag. KitSclavo, Inc.CFRClass II
K831411Glucose Oxidase/peroxidase TestKing Diagnostics, Inc.CGAClass II
K831836Epsilon Ultrasonic TipCooperVision, Inc.HQCClass II
K831831Trulife Silicone Breast FormMedeering, Ltd.GBIClass I
K831785Neuro EaseAndover Medical, Inc.GXYClass II
K831747Plasma Therapy Tubeset-E100 SeriesParker Hannifin Corp.FJKClass II
K831717Coronary Infusion CatheterAdvanced Cardiovascular Systems, Inc.DQYClass II
K831709Audioscope #23000 W/71123 Charging StandWelch Allyn IncERAClass I
K831702Rare-Earth Intra-Ocular MagnetMiami Eye Technology, Inc.HPNClass I
K831691Private Label Deodorant MaxishieldInt'L Consumer DisposablesHHLClass II
K831675Twist Lock Drill 1120Micro-Aire Surgical Instruments, Inc.GETClass I
K831674Rim-Camp TestAustin Biological LaboratoriesJTOClass I
K831673Oxy-SwabAustin Biological LaboratoriesJTOClass I
K831656Arthroscopy Knives/probes/bending ToolRichards Manufacturer Co.HRXClass II
K831647Denture Relining, Repair/rebasing ResinDentsply Intl.EBIClass II
K831637Accu-FlushAccu-LineKRAClass II
K831605Hematology PakMercedes Scientific Co., Inc.IAFClass I
K831597Sero/tex Red Cell RF TestTexas Immunology, Inc.DHRClass II
K831591Aortic Root Cannula W/integral PressDlp, Inc.DWFClass II
K831575Nu-Cap Calcium Hydrox. Pulp CappingCoe Laboratories, Inc.EJKClass II
K831571RotorAmerican Scientific ProductsJJGClass I
K831569Reagent CupsAmerican Scientific ProductsJJGClass I
K831568Reliance Tempo Ophth. Instr StandF. & F. KoenigkramerHHFClass I
K831563Coronary Guiding Catheter-ModifiedAdvanced Cardiovascular Systems, Inc.DQYClass II
K831562Sontek Infusion CatheterSontek Corp.DQOClass II
K831559Certain *Dental RestorativeJohnson & Johnson Professionals, Inc.EBFClass II
K831549Arm SlingsFred Sammons, Inc.ILIClass I
K831535E.p.t. Plus TmWarner-Lambert Co.JHJClass II
K831533Magic T4 125I RadioimmunoassayCorning Medical & ScientificCDXClass II
K831529Ccs Model Sj-103 Implantable AtrialCardiac Control Systems, Inc.DTBClass III
K831528Model Tp Thermistor ProbeScimed Life Systems, Inc.DRFClass II
K831515Dinamap Vital Signs Monitor #1846Critikon Company, LLCDXNClass II
K831514Amwa Tda Theophylline TestMiles Laboratories, Inc.LERClass II
K831500Tri-Level Tdm Control & I II IIIOrtho Diagnostic Systems, Inc.DIFClass I
K831493Denture Adhesive SealsJohnson & Johnson Professionals, Inc.KOTClass I
K831492Yesona Plaster of Paris BandageWatson Phillips Y Cia. Sucs., S.A. de C.V.ITGClass I
K831459Fetal Blood Sampling Kit #1560Transidyne General Corp.HGWClass II
K831456Toxi-Lab Cannabinoid Thc ScreenMarion Laboratories, Inc.DKEClass II
K831434ISO-Sep SystemBerwick Medical Products, Inc.CDPClass II
K831431Audiometer Model-500AudimaxEWOClass II