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 3283 of 3528
510(k) clearances, page 3283 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811832Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp.JJXClass I
K811817Uropaper Eiken AgSyn-Kit, Inc.JILClass II
K811810Uric Acid TestEnvironmental Chemical SpecialtiesKNKClass I
K811806Quick-Chem ColorimeterThe Dow Chemical Co.JJQClass I
K811790Octotoxic ScreenerWestern Advanced Technology, Inc.ETSClass II
K811772Auditory LocalizerWestern Advanced Technology, Inc.ETSClass II
K811767Coltene President Impression MaterialsColtene, Inc.ELWClass II
K811756Therapeutic Drug ControlIcl ScientificDIFClass I
K811751Finetone Model VI Hearing AidVicon Instrument Co.ESDClass I
K811727Portable AudiometersMaico Hearing Instruments, Inc.EWOClass II
K811722Para-PakMeridian Diagnostics, Inc.HYIClass I
K811710Bio.rad Hemoglobin A1 by Column TestBio-RadLCPClass II
K811692Gentamicin Reagent Test KitBeckman Instruments, Inc.LCDClass II
K811683Entri Enternal Feeding SetBiosearch Medical Products, Inc.KNTClass II
K811674Drug StandardsSupelco, Inc.DKBClass II
K811667Coltene Pressure Spot IndicatorColtene, Inc.ELWClass II
K811666Coltene Coltex/coltoflaxColtene, Inc.ELWClass II
K811665Sr-IsocetteJ. Aderer, Inc.ELKClass I
K811594Water PistolAus-Tex Dental Mfg. & DesignEICClass I
K811847Sea Medical Products Lo-VolSea Medical Products, Inc.FPKClass II
K811779Ross-Emerson Pump, Model 55-RJ. H. Emerson Co.KQTClass II
K811773BactagardTri-Med, Inc.FPBClass II
K811432Millipore Dual Rate Intravenous CassetteEMD Millipore CorporationLDRClass II
K810697Axisonic IITeknar, Inc.HDRClass II
K811862Hi-Lo Temp Esophageal StethoscopeMallinckrodt Critical CareBZTClass II
K811857Select-a-FlowWenmar Intl. Corp.KNKClass I
K811856Fluoromatic Theophylline FiaBio-RadLERClass II
K811844Coat-a-Count Gentamicin Ria KitSiemens Healthcare Diagnostics Inc.DJBClass II
K811837i.v. Administration SetMedisystems Corp.FPAClass II
K811833Vnace Fascial Dilator SetVance Products, Inc.KOEClass II
K811826Eosin YSurgipathHYBClass I
K811825Orange G-6SurgipathHZHClass I
K811811Tdm Anti-Convulsant Control Levels I-IIEnvironmental Chemical SpecialtiesDIFClass I
K811809Anti-Arrhythmic Control Levels I & IIEnvironmental Chemical SpecialtiesDIFClass I
K811808Autopak-12 Ferritin KitMicromedic SystemsDBFClass II
K811804Ferritin Ria KitAmersham Corp.DBFClass II
K811792Arrythmia Printer OptionAmerican Edwards LaboratoriesDSIClass II
K811787Quantaphase T-4 RiaBio-RadCDXClass II
K811781TensiometerVivitek, Inc.DXNClass II
K811776Kallestad Quanticoat 125 DigoxinKallestad Laboratories, Inc.DPOClass II
K811775Kallestad Antisera to PhenytoinKallestad Laboratories, Inc.DLPClass II
K811774Open Loop Ambulatory Infusion DeviceCardiac Pacemakers, Inc.FRNClass II
K811771A.d.t. Reusable Bone Marrow NeedleLab Industries, Inc.GAAClass I
K811770Emit-Cad Procainamide AssaySyva Co.LARClass II
K811766Confi-Dry Adult Uroabsorbent PadsPersonal Products Co.HHDClass I
K811760Cholesterol DeterminationBiorent Diagnostic, Inc.CHHClass I
K811749King Diagnostics Phosphorus TestKing Diagnostics, Inc.CEOClass I
K811748King Diagnostics Calcium TestKing Diagnostics, Inc.CICClass II
K811747King Diagnostics Cholesterol TestKing Diagnostics, Inc.CGOClass I
K811746King Diagnostics Cholesterol-Fe TestKing Diagnostics, Inc.CHOClass II