510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3440 of 3526
510(k) clearances, page 3440 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K781207Douche Kit, Something PersonalChatten Drug & Chemical Co.HEDClass I
K781190Infusion Set, Venothin 21Venospital, Inc.FPAClass II
K781189Flu Ven 0151Venospital, Inc.FPAClass II
K781188Infusion Set, Venothin 25Venospital, Inc.FPAClass II
K781187Infusion Set W/ Injection Site, 23D-WVenospital, Inc.FPAClass II
K781186Infusion, Venothin 23Venospital, Inc.FPAClass II
K781185Infusion Set W/ Injection SiteVenospital, Inc.FPAClass II
K781184Infusion Set, Venothin 19Venospital, Inc.FPAClass II
K781171Infusion Pump, Pediatric Model 301Imed Corp.FRNClass II
K781154Syringe, Insulin, HypotipNational Patent Development Corp.FMFClass II
K781136Temperature Module, DualCavitron Corp.FLLClass II
K781132ChemlarHi Chem, Inc.JFSClass II
K781128Ldh (UV Kinetic)Macomb Chemical Co.CFJClass II
K781125Ldh Isoenzyme ReagentElectrophoresis Corp. of AmericaCFEClass II
K781124Cpk Isoenzyme ReagentElectrophoresis Corp. of AmericaJHWClass II
K781123Ponceau SElectrophoresis Corp. of AmericaCEFClass I
K781120Trichloracetic Acid 7.5%Electrophoresis Corp. of AmericaCEFClass I
K781118Eca Buffer Ph 8.8Electrophoresis Corp. of AmericaCEFClass I
K781117Eca PrepElectrophoresis Corp. of AmericaCEFClass I
K781116Eca Buffer, Ph 816Electrophoresis Corp. of AmericaCEFClass I
K781106Thermometer, Exacta TempS.M.B. Celsius Co., Inc.FLKClass II
K781104Plasma Coagulation Cont., AbnormalOrtho Diagnostics, Inc.GFOClass II
K781072Trap-Blood Vessel Stabilization DeviceAyer, Patrick, M.D.JITClass II
K781070Second AntibodyPcl-Ria, Inc.KTSClass II
K781036Auto-Syringe Infusion SetBaxter Healthcare CorporationFPAClass II
K781026Antithrombin III Serum, Anti-HumanIcl ScientificJBQClass II
K780993Ultrasound Imaging SystemBoehringer Mannheim Corp.GADClass I
K780906Air-Flo Alternating Pressure Pad SystemGaymar Industries, Inc.FNMClass II
K780884Hypo-GripHarco ProductsKZAClass I
K780883E-Z-JectorHarco ProductsKZAClass I
K780861Electronic Clinical ThermometerTrend Medical, LLCFLLClass II
K780927Ti-ComforterAlden Products Co.
K780680Unit, Spectra, Corrected, DifferentialRevvity Health Sciences, Inc.
K781052Continuous Epidural Anesthesia TrayAbbott MedicalCAZClass II
K780981Portable Pneumatic Calibrator 65-150Pennwalt Corp.BXXClass I
K781321TENS-O-TestCuromatic, Inc.
K781206Foot PositionerFred Sammons, Inc.IQIClass I
K781205Toilet AidFred Sammons, Inc.ILSClass I
K781204Book HolderFred Sammons, Inc.ILPClass I
K781203Tray, Lap, MoldedFred Sammons, Inc.KNOClass I
K781202Vest, Support, TrunkFred Sammons, Inc.KNOClass I
K781201Board, Transfer, FenderFred Sammons, Inc.IKXClass I
K781200Nail Clippers, One-HandedFred Sammons, Inc.ILWClass I
K781199Holder, Card, Quad-QuipFred Sammons, Inc.ILTClass I
K781198Board, ScooterFred Sammons, Inc.KNLClass I
K781197Stick, UtilityFred Sammons, Inc.ILWClass I
K781196Utensils, WeightedFred Sammons, Inc.ILCClass I
K781195Bag, WalderFred Sammons, Inc.KNOClass I
K781194Bag, WheelchairFred Sammons, Inc.KNOClass I
K781193Knife, Large HandleFred Sammons, Inc.ILCClass I