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 529 of 3529
510(k) clearances, page 529 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K173718Liberty Cycler SetFresenius Medical Care Renal Therapies Group, LLCFKXClass II
K173300ViaTherm BOOSTViatherm Therapeutics, LLCIMJClass II
K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and SetsCook IncorporatedFGEClass II
K172959PeraServer and PeraTrendPerahealth, Inc.MWIClass II
K172656BiliLuxDraeger Medical Systems, Inc.LBIClass II
K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/a Zero GravityOLPClass II
K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingHuiZhou Foryou Medical Devices Co., Ltd.FROUnclassified
K172412BacterioScan 216Dx SystemBacterioscan, Inc.QBQClass I
K180696Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)MEDLINE INDUSTRIES, LP - NorthfieldLZAClass I
K180636ExactVu High Resolution Micro-Ultrasound SystemExact Imaging, Inc.IYOClass II
K180307Mazor XMazor Robotics LtdOLOClass II
K173304Finessis Intense Polyisoprene Surgical GloveLucenxia Prescience AGKGOClass I
K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.EOQClass II
K172636VitaMESH Macroporous PP Surgical MeshProxy Biomedical Ltd.FTLClass II
K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, DisposableJaeger Medical GmbHCCKClass II
K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 MultifocalAlcon LaboratoriesLPLClass II
K180154QiF Blood and Fluid WarmerQuality in Flow Ltd.LGZClass II
K180069HDR MRI Lumen MarkerC4 Imaging LLCJAQClass II
K173390hipEOSOnefit MedicalLLZClass II
K172866NeuroCapMemory MD, Inc.GXYClass II
K172764KeymillMycone Dental Supply Company, Inc. (Aka Keystone Industries)EBIClass II
K172747Hyaluronic Acid Topical Wound CreamVirchow Biotech Pvt. Ltd.FROUnclassified
K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbHJOHClass II
K172460ADHEAR SystemMed-el Elektromedizinische Geraete, GmbHLXBClass II
K172258Novasight Hybrid SystemConavi Medical IncOBJClass II
K172166OLYMPIC Navigated InstrumentsAstura MedicalOLOClass II
K171151ACRON™ TLIF SystemSpinemed Ges.M.B.HMAXClass II
K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve TechnologyC.R. Bard, Inc (Bard Has Joined BD)LJSClass II
K180433Ennovate®Aesculap IncNKBClass II
K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesOlympus Winter & Ibe GmbHGEIClass II
K180037Beacon EUS Access SystemMedtronic, Inc.FCGClass II
K173398Xpert Xpress Strep ACepheidPGXClass II
K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.NAYClass II
K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd.OURClass II
K172955LungVision ToolBodyvision Medical, Ltd.EOQClass II
K172923Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, BlueTop Glove Sdn. Bhd.LZAClass I
K172875Astral 100/150ResMed CorpCBKClass II
K172633INFINITY Total Ankle SystemWrightmedicaltechnologyincHSNClass II
K171872P50 Series Dental Operative Unit and AccessoriesKaVo Dental Technologies, LLCEIAClass I
K1718212 Face / Face EvolutionHeat in a Click LLCNFOClass II
K170339Summit Hip SystemDepuy Orthopaedics Inc.LZOClass II
DEN170028Cala ONECala Health, Inc.QBCClass II
K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact LensContamac Ltd.HQDClass II
K180563syngo.plazaSiemens Healthcare GmbHLLZClass II
K180514Veriton NmSpectrum Dynamics Medical Inc.KPSClass II
K180379RayStation 7RaySearch Laboratories AB (publ)MUJClass II
K180257InCore® Lapidus SystemMedartis AGHWCClass II
K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.OVDClass II
K173782UNiD Patient Specific 3D printed cageMedicrea InternationalMAXClass II
K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block NeedleTeleflex MedicalBSPClass II