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 3075 of 3528
510(k) clearances, page 3075 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K840695Phacoemulsification KitsInnovative Surgical Products, Inc.HQCClass II
K840693Disposable Scleral Globe PlugInnovative Surgical Products, Inc.LXPClass II
K840221Extractable Nuclear Antigen AssayZeus Scientific LLCLLLClass II
K834577I/a Probe LinesFrigitronics of Connecticut, Inc.
K834413Dilation Balloon CatheterHobbs Medical, Inc.FGEClass II
K841838Enriched Culture Med. Tryptic Soy AgarMicroline ScientificKZIClass I
K841837Enriched Culture Med. Fluid Thioglyc0Microline ScientificKZIClass I
K841712Capillary Gas Chromatographic ColumnsSupelco, Inc.DIIClass I
K841673Haemophilus Isolation Agar 2827Gibco Laboratories Life Technologies, Inc.JSJClass I
K841518Johnson & Johnson Posterior Dental (Adaptic II)Johnson & Johnson Professionals, Inc.EBFClass II
K841512Ethox Relia-Flo 2001 Enteral FeedEthox Corp.FRNClass II
K841481Windsor Medical Model 50-00002Windsor Medical, Inc.FRNClass II
K841456Ventrexyme Eia Controls ImmunoassayVxr, Inc.JIXClass II
K841393Ab Manual Ventilation Access. 900CSiemens Elema ABCBKClass II
K841361Syringe Additive IV Admin. SetsQuest Medical, IncFPAClass II
K841280Solopak Brand Filter Needle W/5 MicroSmith & Nephew, Mpl DivisionFPBClass II
K841260Albinar Electronic Digital ThermometerDimension Specialty Co., Inc.FLLClass II
K841200Rubella Igg Antibody Elisa Test SysOrtho Diagnostic Systems, Inc.LFXClass II
K841186Infusion Set Scalp VeinMarbex, Inc.FPAClass II
K841185Plastic, Sterile Tubing Closed SetMarbex, Inc.FPAClass II
K841183Sodium Chloride Solution Blood CellReagent Laboratory, Inc.FNWClass II
K840879Toxo-G Eia Diagnostic KitAbbott MedicalLGDClass II
K840830Ventria Apo a-1 Alpha-1 LipotroteinVentrex Laboratories, Inc.DERClass II
K840803Grams Aspirator S-300Grams Medical, Inc.BTAClass II
K840764Ear KnivesSharpoint, Inc.JYOClass I
K840476Phadexact Serum, Total Ige ControlsPharmacia, Inc.DGCClass II
K840469Tycos Self Check Bpm3 Blood Press MoniSybron Corp.DXNClass II
K840407Kerr Resin Bonded Bridge CementSybron Corp.EMAClass II
K834441Blood Pressure Monitor Bp600xLifeline Systems, Inc.DXNClass II
K833447Cytotoxicity Assay for Clostridium-Bartels Immunodiagnostic Supplies, Inc.MCBClass I
K841397Burn BathSetma, Inc.ILJClass II
K840691Contact Lens Case for Rigid Gas PermaOptimum Manufacturers, Inc.LRXClass II
K840144Yag Laser 8000 Gastrointestinal BleeCooper Medical, SRLFCGClass II
K840142Yag Laser 8000 - Lower Gi ApplicatCooper Lasersonics, Inc.LNKClass II
K841808Stroller SprintCryogenic Assoc.BYJClass II
K8417577200 Microprocessor VentilatorMedtronic, Inc.CBKClass II
K841655Dupont Theophylline Dit CalibratorE.I. Dupont de Nemours & Co., Inc.DLJClass II
K841614Sun BedsSunworld Corp.FTCClass II
K841573Insulin Radioimmunoassay KitSorin Biomedica, Fiat, USA, Inc.CFPClass I
K841572Direct Bilirubin ReagentHi Chem, Inc.CIGClass II
K841471Ultra Chem Enzymatic TriglycerideEm Diagnostic Systems, Inc.CDTClass I
K841466Total Protein Reagent BiuretReagents Applications, Inc.CEKClass II
K841439Coma Toxicology ControlAmerican DadeDIFClass I
K841433Corning Lactate Dehydrophoretic AssayCorning Medical & ScientificCFEClass II
K841418Sodium Electrode Rinse Solution 2Reagent Laboratory, Inc.JGSClass II
K841417Potassium Chloride Solution -2 MolarReagent Laboratory, Inc.JGSClass II
K841388Acufex Shoulder HolderAcufex Microsurgical, Inc.HSTClass I
K841368Hyperbaric Oxygen Gurney-Mizuho Orthopedic Systems IncHSTClass I
K841334Richards Fixator SystemRichards Medical Co., Inc.JECClass II
K841316Flatpack Carrying CaseBausch & Lomb Incorporated