510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
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 3287 of 3528
510(k) clearances, page 3287 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811620Emit-Tox Serum CalibratorsSyva Co.DKBClass II
K811619Emit-St Serum Phenobarbital ControlsSyva Co.LASClass I
K811618Emit-Cad Procainamide/n-Acetyl. ControlSyva Co.DIFClass I
K811617Quantimetric C-Reactive Protein Assay R.Kallestad Laboratories, Inc.DCKClass II
K811612Tryptic Soy AgarMicro Media LaboratoriesJSGClass I
K811611Macconkey AgarMicro Media LaboratoriesJSIClass I
K811610Eosin Methylene Blue Agar (Levine)Micro Media LaboratoriesJSIClass I
K811609Mannitol Salt AgarMicro Media LaboratoriesJSIClass I
K811608Mueller-HintonMicro Media LaboratoriesJTZClass II
K811607Columbia Agar Cna W/5% Sheep BloodMicro Media LaboratoriesJSJClass I
K811606Fluid Thioclycollate MediumMicro Media LaboratoriesJSGClass I
K811605Hektoen Enteric AgarMicro Media LaboratoriesJSIClass I
K811604Xylose Lysine Deoxycholate AgarMicro Media LaboratoriesJSIClass I
K811603Salmonella Shigella AgarMicro Media LaboratoriesJSIClass I
K811602Tryptic Soy BrothMicro Media LaboratoriesJSCClass I
K811601Phenyethyl Alcohol AgarMicro Media LaboratoriesJSJClass I
K811600Bile Esculin MediaMicro Media LaboratoriesJSIClass I
K811599Eosin Methylene Blue AgarMicro Media LaboratoriesJSIClass I
K811598Dnase Agar MediaMicro Media LaboratoriesJSIClass I
K811597Urea Agar SlantMicro Media LaboratoriesJSHClass I
K811596Zimmer Arthroscopy SystemZimmer GmbHHRXClass II
K811588Helena Fetal-Tek 200 MethodHelena Laboratories, Corp.JHGClass II
K811576Cardiozyme Plus Ck-Total Item #65046 (a)HarlecoCGSClass II
K811575Cardiozyme Plus Ck-Mb Item #65045 (G)HarlecoJHWClass II
K811574Cardiozyme Plus Ck-Total Item #65046HarlecoCGSClass II
K811573Cardiozyme Plus Ck-Mb Item #65045HarlecoJHWClass II
K811566C-Terminal Pth by Radioimmunoassay KitImmuno Nuclear Corp.CEWClass II
K811565Acth Radioimmunoassay KitImmuno Nuclear Corp.CKGClass II
K811545Kallestad Quantitope Low Level Ige ReagKallestad Laboratories, Inc.DGCClass II
K811518Vcnt Antibiotic SupplementOxoid U.S.A., Inc.JSKClass I
K811517Vcn SupplementOxoid U.S.A., Inc.JSKClass I
K811516Legionella, Growth & Selective, Supp.Oxoid U.S.A., Inc.JSKClass I
K811515Thioglycollate Med. W/out IndicatorOxoid U.S.A., Inc.JSGClass I
K811514Bacillus Cereus Selective(agar&supp)Oxoid U.S.A., Inc.JSIClass I
K811445Kallestad R Quantiplate Alt. Pathway T.Kallestad Laboratories, Inc.DHLClass I
K811418N-Terminal Hpth by RiaImmuno Nuclear Corp.CEWClass II
K811293Eftekhar Centralizing PlugZimmer GmbHJDIClass II
K811161Humidifier W/ or W/out AdaptorAirlife, Inc.KFZClass I
K810999Cordis Tcpo2 Trancutaneous Oxygen PressCordis US Corp.KLKClass II
K810832ForecasterForecaster Co.LHDUnclassified
K810614Castle Steam Sterilization IndicatorSybron Corp.JOJClass II
K811548Cervical SpatulaProcedure Products, Inc.HHTClass II
K811535Model Fus-1, Flexible UreteroscopeAmerican Optical Corp.FGBClass II
K811457Model Rs-8100Rinal Systems, Inc.KOCClass II
K811444Model Dm-333 Dialysis Control StationExtracorporeal Medical Specialities, Inc.FKQClass II
K811302Somatom 2NSiemens Corp.IZFClass II
K811295Digital Noise ReducerPhilips North America LLCJAAClass II
K811244Cryophthalmic UnitKeeler Instruments, Inc.HRSClass II
K811230X-Cell X-Ray #'S P-75W/p-75MX-Cel X-Ray CorpKPRClass II
K811061Automated Gastric LavageEmergency MedicineKNTClass II