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 3152 of 3528
510(k) clearances, page 3152 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830314Milwaukee Austin Moore Total HipZimmer GmbHJDIClass II
K830270Isovis Wound ProtectorRitmed, Inc.KKXClass II
K823919Total Ossicular ReplacementTreace Medical, Inc.ETAClass II
K823918Austin Modified Partial Ossicular Re-Treace Medical, Inc.ETAClass II
K823917Partial Ossicular ReplacementTreace Medical, Inc.ETAClass II
K823912Austin Modified Total Ossicular ReplaceTreace Medical, Inc.ETAClass II
K831672Spectrum-10Austin Biological LaboratoriesJSSClass I
K831654Rim Beta Lactamase TestAustin Biological LaboratoriesJTOClass I
K831608Fiax Igm Test KitIntl. Diagnostic TechnologyDFTClass II
K831607Fiax Iga Test KitIntl. Diagnostic TechnologyCZNClass II
K831537Paramax Creatine Kinase ReagentAmerican DadeCGSClass II
K831519Rpmi-1640 Medium W/l-Glutamine &Sigma Chemical Co.KITClass I
K831518Auto Carouse/wash Solution ConcentrateSyva Co.JJEClass I
K831498Uri-Test 3, Inlab Reagent Strips-UrinalLaprol Scientific, Inc.JILClass II
K831480Paramax Alkaline Phosphatase Reagent-American DadeCJEClass II
K831478Lyphochek Hemoglobin Aic Control HumanBio-RadLCPClass II
K831470Pth MrRamco Laboratories, Inc.CEWClass II
K831468B Hcg-CheckDiagnostic Technology, Inc.JHJClass II
K831466Hcg-CheckDiagnostic Technology, Inc.JHJClass II
K831446Surgitek Nephrostent KitMec/Surgitek ProductsFADClass II
K831383Event-Test SlideIcl ScientificJHJClass II
K831075Blood Gas & Flame Photometer Instru-United Diagnostics, Inc.CGCClass I
K831026Indirect Fluorescent Antibody ReagentsZeus TechnologiesLHLClass II
K830953Micro Trak Hsv1 & 2 Culture ConfirmationSyva Co.GQLClass II
K830885Gould Model Im3000-Im3100 Battery PowerGould, Inc.DRTClass II
K830791Universal Meddars SystemElectronics for Medicine, Inc.DPSClass II
K830748ResuscitaireVickers America Medical Corp.FMTClass II
K830726Mark I & II Total Knee Replace. SysAdvanced Biosearch Assn.MBVClass II
K831611Uni-ThaneCarapac Systems, Inc.NADClass I
K831520Morwel CannulaMorwel Corp.
K831003Measure-Up Muscle StimulatorMeasure-Up Intl., Inc.IPFClass II
K830622Ortho WrapFast Wrap Co., Inc.FQMClass I
K830830Circa Med Two-ChannelCircadian, Inc.DSIClass II
K831655Spectrum-10Austin Biological LaboratoriesJSZClass I
K831609Fiax Igg Test KitIntl. Diagnostic TechnologyDGKClass II
K831580Paraffin Infiltration MediumSurgipath Medical Industries, Inc.KEOClass I
K831579Gonorrhea Transette 1 & 3Spectrum Diagnostic, Inc.JTWClass I
K831536Paramax Amaline ReagentAmerican DadeJFJClass II
K831499Glucose 3, Inlab Reagent Strips-UrinalyLaprol Scientific, Inc.JINClass I
K831477Demand Analyzer SystemWorthington Diagnostic SystemsJJEClass I
K831244Ureteral Stone Extractor CatheterAmerican Edwards LaboratoriesKODClass II
K830220Yellow Iris TmIntl. Remote Imaging SystemsKQOClass I
K831707Modified Unscented Menstrual PadsPersonal Products Co.HHDClass I
K831693Maxi Pads Scented DeodorizedInt'L Consumer DisposablesHHLClass II
K831692Private Label Deodorant MinishieldsInt'L Consumer Disposables
K831618Hemoglobin ReagentOmega Medical DiagnosticsGKRClass II
K831617DiluentOmega Medical DiagnosticsGIFClass I
K831592Anhydric Incubators, Culture IncubatorBoekel Industries, Inc.JTQClass I
K831589Vent Tube ForcepsTreace Medical, Inc.EQHClass I
K831585Albumin Reagent (BcgReagents Applications, Inc.CIXClass II