510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 1976 of 3531
510(k) clearances, page 1976 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K961448Fuji IX GpGC America Inc.EMAClass II
K961434Vita Zeta Crown and Bridge Acrylic Veneering SystemVidentEBFClass II
K961373Acetaminophen Serum Tox Eia AssayDiagnostic Reagents, Inc.LDPClass II
K961319EpiviewConvatec, A Division of E.R. Squibb & SonsMGPUnclassified
K960882Control SyringeLouisville Laboratories, Inc.FMFClass II
K960392CdmBio-RadLDMClass I
K955772Clinicare Sterile Disposable Syringe/needlesTtk Biomed, Ltd.FMIClass II
K955743Siemens Sc 6000/Sc 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc.DSIClass II
K955608Mccoy Cell CulturesVai Diagnostics, Inc.KIRClass I
K962432Liquispex Urine (Micro)albumin ControlClinical Controls, Inc.JJXClass I
K962395Specimen Retrieval BagApplied Medical Resources CorpGCJClass II
K962032Karl Storz Twin TransilluminatorKarl Storz Endoscopy-America, Inc.MQWClass I
K961803Spuncrit (Model Drc-40)Micro Diagnostics Corp.GKGClass II
K961648The WandSpintech, Inc.EJIClass II
K961557Alliance 2690 Separations ModuleWaters CorporationLDMClass I
K961519Etest Submission for AzithromycinAb BiodiskJWYClass II
K961517Etest Submission for CefotetanAb BiodiskJWYClass II
K961482Duracon Inset Patella with Central PegHowmedica Corp.JWHClass II
K961274Olympus Au600 Clinical Chemistry AnalyzerOLYMPUS Corporation of the AmericasJJEClass I
K961011Dtx-200 Bone DensitometerShotwell & Carr, Inc.KGIClass II
K960888Chek-Stix U.t.i. Self-TestBayer Corp.JMTClass I
K960497Flexible Phased Array Spine CoilPhilips North America LLCLNHClass II
K955845Ll 100, 103, 104 Diagnostic Laparoscope Rigid Rod LensSurgical Image Laboratories, Inc.GCJClass II
K951965Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDako Corp.DEHClass II
K962412Nike V8 and Nike V12Nike, Inc.HQYClass I
K962338Radiographic GridUnidex Group, Inc.IXJClass I
K962336Radiographic Film CassettesUnidex Group, Inc.IXAClass II
K962310Non-GenericClassic Elegance Intl., Inc.HQYClass I
K962290Deroyal Industries, Inc. Neonatal Eye CoverDebusk Technology Corp.FOKClass I
K962277Self Cure Bonding AgentDent Zar, Inc.KLEClass II
K961993Birthday Kit (Obstetrical Delivery Kit)Devon Industries, Inc.MLSClass II
K961944Lunar Report GeneratorLunar Corp.KGIClass II
K961907Rionet Hearing Aid Hb53-KAuthorized Hearing Systems, Inc.ESDClass I
K961857Labtron Electromax Electronic Stethoscope Model No. 04-1060Graham-Field, Inc.DQDClass II
K961827In-the-EarQualitoneESDClass I
K961680Sony Dkr-700 Digital Still RecorderSony Medical SystemsLMBClass I
K961637Picker Mr Workstations (Vistar,montage and Oncall)Philips North America LLCLLZClass II
K961632Micro-Touch Powder Free Latex Surgical GlovesJohnson & Johnson MEDICAL GmbHKGOClass I
K961506Microspan Hysteroscope SheathImagyn Medical, Inc.HIHClass II
K961464Select/spElscint, Inc.JAKClass II
K961451DicomnetLockheed Martin Communications SystemsIZIClass II
K961403Life Imaging Systems Lis 6000 aLife Imaging Systems, Inc.LLZClass II
K961377Manan Prostate Locking Introducer SetArgon Medical Devices, IncIWJClass I
K961366Model #Qsc-200-4C and Qsc-165-4C Array Shoulder CoilsMri Devices Corp.LNHClass II
K961339Carbo Brand/viva Brand Acupuncture NeedlesHelio Medical Supplies, Inc.MQXClass II
K961294Scimed Dispatch Gold Coronary CatheterScimed Life Systems, Inc.KRAClass II
K960391Strato/infusaid Periport Infusion Set 41770,41771Strato/Infusaid, Inc.FPAClass II
K960265Advantage Windows with Functool OptionGE HealthcareLLZClass II
K954737Surface Electromyograph Biofeedback Muscle Activity DeviceJ-Tech, Inc.HCCClass II
K941460Fresenius Blood Temperature MonitorFresenius USA, Inc.MQSClass II