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 3192 of 3528
510(k) clearances, page 3192 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K823320Dental Instruments - Bone ChiselsMiltex, Inc.EMLClass I
K823319Dental Instruments - ScalersMiltex, Inc.EMSClass I
K823318Dental Instruments - ExcavatorsMiltex, Inc.EKSClass I
K823317Dental Instruments - ExplorersMiltex, Inc.
K823316Dental Instruments - FilesMiltex, Inc.EKSClass I
K823315Dental Instruments - KnivesMiltex, Inc.EJZClass I
K823314Dental InstrumentsMiltex, Inc.EJLClass I
K823305Dento Spray Oral IrrigatorNeo-Life Co. of AmericaEFSClass I
K823276Bed GuardT. S. Enterprises, Inc.KPNClass II
K823260Interface Cardiotomy Blood Filter #51Medical, Inc.JODClass II
K823259Interface Cardiotomy Blood Filter #50Medical, Inc.JODClass II
K823258Interface Arterial Blood Filter #40Medical, Inc.DTMClass II
K823249Lifescope Ii/fourNihon Kohden America IncDRGClass II
K823220CosmosNihon Kohden America IncDPSClass II
K823215Ckg 8800Cardio Kinetics, Inc.DSBClass II
K823210Model 525 Neo-Trak Neonatal RecorderGE Medical Systems Information Technologies, Inc.DSFClass I
K823205Exv Venous Reservoir Bag & HolderExtracorporeal Medical Specialities, Inc.DTNClass II
K823125Capiox IITerumo Medical Corp.DTZClass II
K823080VakutageWeston, Copco, Inc.HHKClass II
K823041Jeol Model #Jtg-500MJeolIYMClass III
K823035Computer Interface Module CimYFRNClass II
K822983Mingocard 7 & Mingophone 7Siemens Corp.DSFClass I
K822939Heart Rate & Temp. Measurement SystemCamino Laboratories, Inc.FLLClass II
K822926Model Ls-85 & Medel 1828 Linescan ViscoHoneywell, Inc.
K822891Flo ControlDna Medical, Inc.LDRClass II
K822704Model 366-07 Adapt Aid Lead AdapterIntermedics, Inc.DTDClass II
K822102Press-O-TestMedi-Swiss Corp.DXNClass II
K827383Model 900 Photocoagulator with Green-Only OptionsCoherent Radiation Laboratories
K823365Hearing Aid Ue-10Unitron Industries, Inc.ESDClass I
K823280DistaflexDuradent Corp.EGGClass I
K823279Respond Quadriflex #3129 Single ChannelMedtronic, Inc.IPFClass II
K823278Dental Floss TipSanderson Creative Products Co.JESClass I
K823255Non-Sterile Reusable NeedlesVertex Medical Corp.FMIClass II
K823227Impedance Meter on-1Kells Medical, Inc.ETYClass II
K823226Sn-100 Doctor's RoundKells Medical, Inc.ETFClass I
K823223View-Pack & Multi PouchSbw Medical Packaging, Inc.FRGClass II
K823213Diagnostics Alkaline Phosphatase OptimiBoehringer Mannheim Corp.CJEClass II
K823211Ck-UV ReagentBiorent Diagnostic, Inc.JHSClass II
K823187Cholesterol High Sensit. Reagent EnzymRai, Inc.CHHClass I
K823185Gamma Light Curing Dental RestorativeJohnson & Johnson Professionals, Inc.EBFClass II
K823180Sa-21 Dental UnitRitter GmbHEIAClass I
K823176Monoject Samplette Capillary Serum SepSherwood Medical Co.JKAClass II
K823173Arrirm Scrub Brush/spongeThe Buckeye Cellulose Corp.GECClass I
K823147Uric Acid Standard, 8Mg/dl #65078Harleco DiagnosticsJISClass II
K823124Ims Hematology MixerInnovative Medical Systems, Inc.GLEClass I
K823111Nystymograph AccessKelleher Corp.GNNClass I
K823092Hemaflo Blood Tubing SetsCobe Laboratories, Inc.FKQClass II
K823090Raichem & Gt ReagentReagents Applications, Inc.JPZClass I
K823060Hemoglobin ReagentBiorent Diagnostic, Inc.KHGClass II
K823027Accudot 380 Secondary i.v. SetImed Corp.FPAClass II