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 3230 of 3528
510(k) clearances, page 3230 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821122Operating 5 & 1/2 Straigh Sharp/bluntConphar, Inc.FZTClass I
K821121Scissors 5 & 1/2Straight Blunt/bluntConphar, Inc.FZTClass I
K821120Operating Scissors Curved 4 & 1/2 BluntConphar, Inc.FZTClass I
K821119Operating Scissors 4 & 1/2 Blunt/bluntConphar, Inc.FZTClass I
K821118Bandage Scissors 4 & 1/2Conphar, Inc.FZTClass I
K821117Scissors Straight 5&1/2SharpConphar, Inc.FZTClass I
K821116Lister Bandage Scissors 5 & 1/2Conphar, Inc.FZTClass I
K821115Scissors Curved 4 & 1/2 SharpConphar, Inc.FZTClass I
K821114Operating Scissors Curved 6 & 1/2 SharpConphar, Inc.FZTClass I
K821113Operating Scissors 5&1/2 Curved SharpConphar, Inc.FZTClass I
K821112Conphar Scissors 4&1/2 Sharp BluntConphar, Inc.FZTClass I
K821111Conphar Scissors 4&Ahalf SharpsharpConphar, Inc.FZTClass I
K821094Ip Specific EDiagnostic Reagent Tech.DGOClass II
K821073Pulse GeneratorBiotronik Sales, Inc.DXYClass III
K821003Programmalith II, #225 & 226Pacesetter SystemsDXYClass III
K820875AutostikMarquest Medical Products, Inc.CBTClass I
K820712Sepcor Unit Collection MonitorSeparation Science Corp.KSQClass I
K820653Ote Biomedica Berg Fourier AnalyzerDel Mar AvionicsOLTClass II
K820367Intra-Articular Surgical SystemDyonics, Inc.KIJClass I
K813638Multi-Unit, Multi-Purpose DeviceThe Scott & Fetzer Co.EFSClass I
K821148Ethox Food Pump Stand W/pole ClampEthox Corp.FRNClass II
K821106Triglyzyme V EikenSyn-Kit, Inc.JGYClass I
K821105Cholestezyme-V EikenSyn-Kit, Inc.CHHClass I
K821102Megnesium Reagent KitAnco Medical Reagents & Assoc.JGJClass I
K821101Total Radioimmunoassay KitBioclinical GroupCDXClass II
K821097Systemic Lupus Erythermatosus Anti-N-DNAIcl Scientific
K821068Dsl 1020Diagnostic Systems Laboratories, Inc.CGRClass II
K821042Model Im9Marcon Hearing Instruments, Inc.ESDClass I
K820993Audio-Adi, Aa SeriesAudio-Aid, Inc.ESDClass I
K820955Bond-onJ. Aderer, Inc.EJSClass II
K820944Dental Arch BarUnisplint Corp.DYXClass II
K820907DentiscopeChayes Virginia, Inc.EAYClass I
K820903Thc-Cannabinoids Direct Urine Ria KitImmunalysis CorporationLATClass II
K820897Ventre/spec Ige ControlsVentrex Laboratories, Inc.DGCClass II
K820892Bosworth Wooden WedgesHarry J. Bosworth Co.
K820889Aspirator/irrigator or I/a UnitMid Laboratories, Inc.KYGClass I
K820869Disposable #11 Scalpel Blade W/shortVan-Tec, Inc.GDXClass I
K820865Van-Tec Fascial DilatorVan-Tec, Inc.GCCClass I
K820817Optacry/95 Gray Contact Lens BlanksOptacryl, Inc.HPXUnclassified
K820816Optacry/ 95 Green Contact Lens BlanksOptacryl, Inc.HPXUnclassified
K820815Optacry/95 Blue Contact Lens BlanksOptacryl, Inc.HPXUnclassified
K820594Biostrip GHelena Laboratories, Corp.JILClass II
K820252Tbg Diagnostic KitDiagnostic Reagents, Inc.CEEClass II
K820251T4 Diagnostic KitDiagnostic Reagents, Inc.CDPClass II
K813056Automated Urinalysis SystemKyoto Daiichi Kagaku Co., Ltd.KQOClass I
K821086M T M CircuitMedical Technology Mix, Inc.CAIClass I
K821064Inspiron Neonatal Ventilator CircuitC.R. Bard IncBZOClass I
K821061Ace Albumin CalibratorE.I. Dupont de Nemours & Co., Inc.JISClass II
K821058715 Delta TerminalCorning Medical & ScientificJQPClass I
K821048Liquid-Stat Tm Ast-UV Liquid EnzuneBeckman Instruments, Inc.CKAClass I