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 3109 of 3528
510(k) clearances, page 3109 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K832634Selectrode SystemBio-Stimu Trend Corp.BWKUnclassified
K831118Pmt-Optica LinePmt, Inc.KDCClass I
K834605C4 Antigen Antibody ControlTechnicon Instruments Corp.DBIClass II
K834604C3 Antiserum ControlTechnicon Instruments Corp.CZWClass II
K834555Bear Venti--VoiceBear Medical Systems, Inc.ESEClass I
K834294Eltrachem Diatrac Glycosylated HemoglobEMD Millipore CorporationLCPClass II
K834244Theofast Test Kit for Quantitative TheoAllergeneticsKLSClass II
K834216Emit Qst Phenobarbital AssaySyva Co.DLZClass II
K834052Chemkit Carbamazepine Diagnostic KitAbbott MedicalKLTClass II
K834023Bio-Science Laboratories T4 ReagentBiosan Laboratories, Inc.CDXClass II
K833992Technicon Ra-1000 SystemTechnicon Instruments Corp.JGSClass II
K833959Microlab M Diluter/dispenserSyva Co.JQWClass I
K833925Coat-a-Count Nhs-Prolactin Kit andSiemens Healthcare Diagnostics Inc.CFTClass I
K833911Urine Thc Cannabinoids Direct Ria KitImmunalysis CorporationLATClass II
K833794Lyphochek Therapeutic Drug ControlBio-RadDIFClass I
K833789Phase II Theophylline RadioimmunoassayMedical & Scientific Designs, Inc.LCAClass II
K833788Filafex Esthetic Orthodinic WireBerkley and Co.DZCClass I
K833774Naturelle II & Lite II-N72-N74-LJeneric Ind.EJSClass II
K833406Immophase D-Te 3 RadioimmunoassayCorning Medical & ScientificCGFClass I
K833402Tech. Ra-1000Sys-Analytes ImmunoglobulinTechnicon Instruments Corp.DEWClass II
K833086Neurotron 100Neutro-TronicsGZJClass II
K832796Star Hcg Monoclonal Antibody ImmunoradSyncor Intl. Corp.JHIClass II
K831838Laboratory Data Mgmt System SdmsVickers America Medical Corp.JQPClass I
K840266K-Flex Ostomy PouchMEDLINE INDUSTRIES, LP - Northfield
K834140Antinuclear Antibody Immunological SysIntl. Diagnostic TechnologyKTLClass II
K832438Chloride Reagent SetAmresco, Inc.CHJClass II
K823780Respitrace 300ScRespitrace Corp.BZKClass II
K832407Decubitus Care Absorbent DressingAmerican Pharmaseal Div. AhscFROUnclassified
K834454Paediatric Face Mask 1-3 W/wo RingWarne Surgical Products, Ltd.BSJClass I
K834250Rescue MaskRondex Products, Inc.BTMClass II
K833850T4 RiaSyncor Intl. Corp.CDXClass II
K833781Durazyme CpkAmerican Monitor Corp.CGSClass II
K833772Auto Aic Analyzer SystemHelena Laboratories, Corp.LCPClass II
K833696Acid Base Laboratory Abl4Radiometer America, IncCEMClass II
K833650Yasargil Standard Aneurysm Clip &Advanced Biosearch Assn.HCHClass II
K833194Tandem R-Total B-Gcg KitHybritech, Inc.JHIClass II
K833137Ortho B-Hcg Slide Test for PregnancyOrtho Diagnostic Systems, Inc.JHJClass II
K832888ECG Interference Filter Tf-03La Jolla Technology, Inc.DPSClass II
K840015Swivel Adaptor W/alarm PortAbbott MedicalBZAClass I
K834565Endobronchial Twin Lumen TubeAbbott MedicalBTSClass II
K834522Venti-Voice Nasal CatheterRespiratory Support Products, Inc.ESEClass I
K834517Jay CushionJay Medical, Ltd.KICClass I
K834507Hydropulse(grossan);inflat Tube MassAmrex-Zetron, Inc.IRPClass II
K834427Thiogel Medium TubeOtisville Biotech, Inc.JSGClass I
K834426Loeffler Medium TubeOtisville Biotech, Inc.JSGClass I
K834425Cta Medium TubeOtisville Biotech, Inc.JSGClass I
K834418Cdc Anaerobe Blood Agar PlateOtisville Biotech, Inc.JSGClass I
K834417Campy Brucella Agar PlateOtisville Biotech, Inc.JSJClass I
K834411Techmedica-Hewson Shoulder CleatTechmedica, Inc.HTNClass II
K834399New Mother's Way-Breast PumpHuntleigh Technology, Inc.HGYClass I