510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2945 of 3529
510(k) clearances, page 2945 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K854453P.e.z. Agar (Phenylethanol Agar)R. Kent Richards, Inc.JSJClass I
K854452Mannitol Salt AgarR. Kent Richards, Inc.JSIClass I
K854451Mueller Hinton MediumR. Kent Richards, Inc.JTZClass II
K854450Bile Esculin Azide AgarR. Kent Richards, Inc.JSIClass I
K854449Hektoen Enteric AgarR. Kent Richards, Inc.JSIClass I
K854346Mediflex Disposable Tubing ClampMediflex Intl.FPAClass II
K854257Combo 36Kg Engineering, Inc.FNJClass I
K853969Phadebas Rast Test Allergen DiscsPharmacia, Inc.DHBClass II
K853882Super SlickTang ProductsKMTClass I
K853648Synectics Liberty Sys Compris Digitrapper Mk II MoSynectics-DantecFFTClass I
K853393Insulin Pump Insumat 229Medix Medical Electronics (U.S.A.), Inc.FRNClass II
K853260Omron Digital Bp Monitor Hem-700COmron Tateisi Electronics Co.DXNClass II
K853141Access Digiwipe SystemMedTech Products, Inc.KHEClass II
K853047Monaghan Rvm, Model 760 or Model 761Monaghan Medical Corp.BZQClass II
K852795Sunbeam Health Monitor Model No. 7600Aanson Scale Co.DXNClass II
K852254i.v. Stat MasterThe Master Medical Corp.FPAClass II
K852167Isovol-Exchange TrayRocky Mountain Medical Corp.BRZClass II
K853759Custom Procedural Tray Procedural KitCharles Atkins & Co.
K854340Technicare 720 Hps CT ScannerTechnicare Corp.JAKClass II
K854339Cui Chin SizerCox-Uphuff Intl.
K854313Songer Titanium Spine-L-RodOrtho-Engineering Products Co.KWPClass II
K854254Tension-IsometerMedmetric Corp.LXIClass I
K854248Goodley Polyaxial Cervical Traction UnitE-Z-EM, Inc
K854159Ellipti-PunchAlcon LaboratoriesFZIClass II
K854072Johns-Allgood Irrivac Drive-Irrigator/aspirator-Dexide, Inc.
K854020G-T 1000G-T ProductsFTCClass II
K853844Duoderm Hydroactive Dressing W/border SterileConvatec, A Division of E.R. Squibb & SonsFROUnclassified
K853709A Range of Instruments & Plates for Mandibular ComDowns Surgical, Ltd.HRSClass II
K853408Collar Less Aml HipDepuy, Inc.JDIClass II
K853330Boomerang Absorption Comensation FilterEntreprises Octostop, Inc.KPRClass II
K854239OxycoilChad Therapeutics, Inc.BYXClass I
K854103Sceptor Enteric Mic/id PanelBD Becton Dickinson Vacutainer Systems PreanalyticJWYClass II
K854102Sceptor Enteric Mic PanelBD Becton Dickinson Vacutainer Systems PreanalyticJWYClass II
K854101Sceptor Gram Positive Mic PanelBD Becton Dickinson Vacutainer Systems PreanalyticJWYClass II
K854100Sceptor Gram Positive Mic/id PanelBD Becton Dickinson Vacutainer Systems PreanalyticJWYClass II
K854099Sceptor Gram Negative Urine Isolate Mic/id PanelBD Becton Dickinson Vacutainer Systems PreanalyticJWYClass II
K854098Sceptor Pseudomonas Plus Mic PanelBD Becton Dickinson Vacutainer Systems PreanalyticJWYClass II
K854097Sceptor Pseudomonas Plus Mic/id PanelBD Becton Dickinson Vacutainer Systems PreanalyticJWYClass II
K853968Diatemp Electrosurgical PenNdm Corp.GEIClass II
K853922Plotter for as-500Riko Medical & Scientific Instrument Corp.BZHClass II
K853741Indontinence PadBeghin_Say Intl., Inc.
K853698Scotchprime Ceramic Primer3M CompanyEIHClass II
K853643Multistim Laminectomy ElectrodeNeuromed, Inc.GZBClass II
K853586Pressure Sensing Syringe 65000Dlp, Inc.DTLClass II
K853516Sarns Retrograde Cardioplegia Delivery System3M Health Care, SarnsDTRClass II
K853503Shiley 3L Cardiotomy ReservoirShiley, Inc.DTPClass II
K853352Fukuda Denshi Ds-1060 Dynascope Patient MonitorFukuda Denshi USA, Inc.DSIClass II
K853158Digital Sphygmomanometer Model 7620Takeda Medical, Inc.DXNClass II
K853137Cmv TestGull Laboratories, Inc.GQIClass II
K852968Pcm Digital Ambula Tory ECG Analysis SystemPersonal Computers for Medicine, Inc.DSIClass II