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 3132 of 3528
510(k) clearances, page 3132 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K832641Windsor Medical Model 52Windsor Medical, Inc.FRNClass II
K832640Quick-Tell Indirect Pregnancy TestStanbio LaboratoryJHJClass II
K832635Hi-Lo Temp Tympanic Temp. SensorMallinckrodt Critical CareFLLClass II
K832587Rime Coli KitAustin Biological LaboratoriesJTOClass I
K832536Brilliant Green Agar PlateOtisville Biotech, Inc.JSJClass I
K832535Hektoen Enteric Agar PlateOtisville Biotech, Inc.JSIClass I
K832534Sheep Blood Agar PlateOtisville Biotech, Inc.JSGClass I
K832533Selenite Cystine BrothOtisville Biotech, Inc.KZIClass I
K832525Irrigation/aspiration PackIntermedics Intraocular, Inc.
K832524Baird Parker Agar PlateOtisville Biotech, Inc.JSIClass I
K832523Tryptose Sulfite Cycloserine Agar PlateOtisville Biotech, Inc.JSIClass I
K832497Cavity CleanserDen-Mat Corp.LBHClass II
K832435Brook Life Saving Airway Device #900 &La Societe Fianciere SenefinCAEClass I
K832425Great Lakes Paste SolderGreat Lakes Orthodontics, Ltd.EJSClass II
K832413Sias Irrigation/aspiration SystemClark Pool & Assoc.HQCClass II
K832378Vibratory Endodontic SystemSyntex Dental Products, Inc.EKQClass I
K832341Arthroscope-Various Models FiberopticKamiya Tsusan Kaisha, Ltd.HRXClass II
K832315Arthroscopy Fluid Mgmt. System3M Health Care, SarnsHRXClass II
K832300i.v. Filter HolderSaxnor Corp.KMKClass I
K832179Hot Probe Model 6001Analytic TechnologyEEGClass I
K832171Self Check Digital Blood Press. MonitorRitter GmbHDXNClass II
K832100Psi Surgical AspiratorAdvanced Biosearch Assn.BTAClass II
K832045Acetaminopher Assay KitQuantimetrix Corp.LDPClass II
K831931Atrium Thoracic CatheterAtrium Medical CorporationGBZClass I
K831481Dixie USA Ptl, Pharyngeal Tracheal LumenEugene ScarberryDSKClass II
K831374Med Care Prep RazorMedcare Products
K830800C-LoopsConcept, Inc.KDCClass I
K832994Midas 6000 Automatic StainerInnovative Medical Systems, Inc.KPAClass I
K832970Cane ReacherMaddak, Inc.IPSClass I
K832969Walking CaneMaddak, Inc.IPSClass I
K832968Pedal ExerciserMaddak, Inc.IONClass I
K832957Flow-Directed Heparin Coated ThermodilSorensen ResearchDYGClass II
K832955Bacteroides Bile Esculin AgarBD Becton Dickinson Vacutainer Systems PreanalyticJSIClass I
K832954V AgarBD Becton Dickinson Vacutainer Systems PreanalyticJSIClass I
K832953Mucicarmine Stain, #Ht30Sigma Chemical Co.HZCClass I
K832948Nyc-Gc MediaOtisville Biotech, Inc.JTYClass II
K832947Ortho Cell Cultures-Mrc-5 Human EmbryoOrtho Diagnostic Systems, Inc.KIRClass I
K832934Macconkey's Agar PlateOtisville Biotech, Inc.
K832930Spinner Salt Solution S-6011 W/earlesSigma Chemical Co.KITClass I
K832929Ristocetin Platelet Aggrega-Reagent TestSigma Chemical Co.JBXClass II
K832911Abbott Globe HolderMiami Eye Technology, Inc.HJOClass II
K832865Flex Bubble TubingSheridan Catheter Corp.BYYClass II
K832858Intradiscal Therapy TrayUlti-Med Intl., Inc.FMIClass II
K832855Tpe Diamond PointsShofu Dental Corp.DZPClass I
K832852Blaise-Rathael Voice ProsthesisRichards Medical Co., Inc.EWLClass II
K832844Ruby Knives for Ophth. SurgeryKeeler Instruments, Inc.HNNClass I
K832842Dulbeccos Modified Eagles Medium D5648Sigma Chemical Co.KITClass I
K832841Nutrient Mixture F12 #N6760 W/l-GlutamSigma Chemical Co.KITClass I
K832836Basal Med. #B9763 W/hanks Salts W/l-GSigma Chemical Co.KITClass I
K832835Dulbeccos Phosphate Buffered SalineSigma Chemical Co.KITClass I