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 3293 of 3528
510(k) clearances, page 3293 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811171Vasculon II i.v. CatheterPioneer Viggo, Inc.FOZClass II
K811164Urethane Orthopaedic Casting TapeHexcel MedicalITGClass I
K811159Dynasound 801Dynawave, Corp.IMIClass II
K811158OmniOmni Hearing SystemsESDClass I
K811157Blade, TongueDyn-A-Med Products
K811123Medtronic Pulse GeneratorMedtronic, Inc.DXYClass III
K811106Intermedics Poly Flex Endocardial PacingIntermedics, Inc.DTBClass III
K811068Bypass CoilG.D. Searle and Co.KPYClass I
K811059Pentax Bronchofiberscope #Fb-15APentax Precision Instrument Corp.EOQClass II
K811030Appose Skin StaplerDavis & Geck, Inc.GAGClass II
K811017Huckstep Intramedullary NailDowns Surgical, Ltd.KTTClass II
K810882Asr-3520 Skin Response Monitor;asr-3520AAtlas Researches, Ltd.HCCClass II
K810881EMG 3510/Emg 3510D Myofeedback MonitorsAtlas Researches, Ltd.HCCClass II
K810880Ar-1 Physiological ProdessorAtlas Researches, Ltd.HCCClass II
K810801Dentmed V-PacksUniv. of Bristol Dental SchoolEFQUnclassified
K810722Gastrin Radioimmunoassay TestClinical Assays, Inc.CGCClass I
K810677Models 5976/5977 Pacemaker Pulse GenerMedtronic, Inc.DXYClass III
K810317Nitroglycerine IV SetAbbott MedicalFPAClass II
K803208Sirecust 358Siemens Corp.DSIClass II
K811251Citrate BufferBioscientificJCCClass I
K811249Technicon Smac II System & AccessoriesTechnicon Instruments Corp.JJCClass I
K811242Disposable Sterilization WrapAmsco Co.FRGClass II
K811232Disposable UnderpadsBurinaKMEClass I
K811223Vasovasostomy Stabilizer Platform DevZimmer GmbHKOAClass I
K811222Inorganic Phosphorus ReagentsConnecticut Diagnostics, Ltd.CEDClass I
K811219Kova Strip 6Icl ScientificJIRClass I
K811214Assure Natural Fit TamponPersonal Products Co.HILClass II
K811212Digoxin (Ria) KitImmuno Assay Corp.DNLClass II
K811208Model 1100 SphygmomanometerYDSKClass II
K811206Self Heating Disposable Heat PadEnsar Corp.IMDClass I
K811205Molded Polysulfone Trial ProsthesisShannon GroupHWTClass I
K811204Bronchek-Shiley Cardiac Jacket & Bsc JShiley, Inc.DTRClass II
K811203Saf Single-Use Aerosol FilterSorensen ResearchGCYClass I
K811201Eftekhar Acetabular StandoffZimmer GmbH
K811199Marz-175Emde Corp.CBTClass I
K811167Focus Sterile SyringesStanford LaboratoriesFMFClass II
K811163Sur-Fit Disposable Fange CapE. R. Squibb & Sons, Inc.EXBClass I
K811082Beta I & Beta IIPorta Ray, Inc.IZLClass II
K810995Prefilled Pulsator SyringeConcord Laboratories, Inc.FMFClass II
K810973System 400Philips North America LLCKPRClass II
K810921Male Luer Lock PlugsProcedure Products, Inc.FPAClass II
K810918Roll-a-SetPrinciple Business Ent.FRGClass II
K803249Fluid WarmerDatachem, Inc.LGZClass II
K811184Spenco Dermal PadsSpenco Medical Corp.FMPClass I
K810332Sc/temp 300Thought Technology Ltd.HCCClass II
K811188Norelco Blood Pressure MeterNorth American Philips Corp.DXNClass II
K811182Multianalyte Controls, All KindsFisher Scientific Company L.L.C.JJYClass I
K811180Ultramatic Project-O-Chart Ophth. ProjAmerican Optical Corp.HOSClass I
K811179Osmometer Model Om-6010Fiske Med ScienceJJMClass I
K811178Human Igg-Albumin Test KitMeloy Laboratories, Inc.CJQClass II