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 3272 of 3528
510(k) clearances, page 3272 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K812483Secura Bath SeatMaddak, Inc.ILSClass I
K812481BackrestMaddak, Inc.
K812480Limb Holder Arm SlingMaddak, Inc.ILIClass I
K812478Maddacomfort SlingMaddak, Inc.ILIClass I
K812477Arm Sling, Pouch TypeMaddak, Inc.ILIClass I
K812475Transfer BenchMaddak, Inc.IKXClass I
K812474Baby Walker W/toy ChestMaddak, Inc.IONClass I
K812472Spin-Chem Ld-L ReagentSmithkline Diagnostics, Inc.CFJClass II
K812471Spin-Chem Triglycerides ReagentSmithkline Diagnostics, Inc.CDTClass I
K812470Hipp MicrotubeCarr MicrobiologicalsJSFClass I
K812469Rapid Decarboxylase/dihydrolase MicrotubCarr MicrobiologicalsJSFClass I
K812468Pyrr MicrotubeCarr MicrobiologicalsJSFClass I
K812467Pgua-Indol MicrotubeCarr MicrobiologicalsJSEClass I
K812466Onpx-Indol Medium MicrotubesCarr MicrobiologicalsJSEClass I
K812465Phos MicrotubesCarr MicrobiologicalsJSFClass I
K812423Neoprene Knee SupportSurgical Appliance Industries, Inc.ITQClass I
K812422Custom Contour Lumbosacral OrthosisSurgical Appliance Industries, Inc.IPYClass I
K812414Kallestad 125I Antiserum to Human IgeKallestad Laboratories, Inc.DHBClass II
K812401Cruciform Anterior Spinal Hyperexten. OSurgical Appliance Industries, Inc.IPTClass I
K812399Chair, Adjustable, MechanicalKaye Products, Inc.INNClass I
K812352Hygiene AdaptorsFred Sammons, Inc.ILSClass I
K812351Non-Measuring ExercisersFred Sammons, Inc.IONClass I
K812350Wheelchair AccessoriesFred Sammons, Inc.KNOClass I
K812349Hand Splints & ComponentsFred Sammons, Inc.ILHClass I
K812348Desk Arm Wheelchair Arm ExtensionFred Sammons, Inc.KNNClass I
K812347Raised Chair W/foot PlatformFred Sammons, Inc.INNClass I
K812346Aluminum Scoop DiskFred Sammons, Inc.ILCClass I
K812345Arm SlingsFred Sammons, Inc.ILIClass I
K812344Heel or Elbow ProtectorFred Sammons, Inc.FMPClass I
K812343Pinch MeterFred Sammons, Inc.HRWClass I
K812299Electro-SnapRodel Products Corp.GXYClass II
K812291Ethicon Multiple Ligating Clip ApplierEthicon, IncGDOClass I
K812238D.i.v.a.s.Cgr Medical Corp.IZIClass II
K812234Storz/olympus Microscope SystemStorz Instrument Co.EPTClass I
K812210Creat Brand Wagner Chin ImplantAesthetech Corp.FWPClass II
K812198Accessories(probes, Suction Tubes, Etc.)Reznik InstrumentsGEIClass II
K812105Anogo Disposable Shoe CoverAnago, Inc.BWPClass I
K811935Prolene Polypropylene Ligating ClipEthicon, IncFZPClass II
K811783EndopumpMedtron Development, Ltd.FRNClass II
K811753Surgeon's GlovesTravenol Laboratories, S.A.KGOClass I
K811632Unsterilized Laparotomy Sponges (China)Robert I. Chien & Assoc., Inc.GDYClass I
K810902Ip-758 Burn Wound DressingExopackNAEClass I
K812452Alkaline PhosphataseHoriba Instruments IncorporatedCJEClass II
K812447Amylase Reagent KitBioscientificKHMClass II
K812430Uric Acid Reagent SetHoriba Instruments IncorporatedKNKClass I
K812417Blood Urea Nitrogen(bun-UV)Reagents Applications, Inc.CDQClass II
K812415Kallestad Antisera to TobramycinKallestad Laboratories, Inc.KLBClass II
K812404Butterfly Needle AssemblyNu Tech Medical SystemsFMIClass II
K812403Scented Menstrual PadsProcter & Gamble Mfg. Co.HHLClass II
K812402Unscented Menstrual PadsProcter & Gamble Mfg. Co.HHDClass I