510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 of the 176,466 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
20262,669
176,466 records, page 2538 of 3530
510(k) clearances, page 2538 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K901138Autovac(r) Autotransfusion System, 7900 SeriesBoehringer Laboratories, LLCCACClass II
K901041Ionometer Eh-Hk and AccessoriesFresenius USA, Inc.CEMClass II
K900465Max Transport VentilatorHamilton Medical AGCBKClass II
K900218J&s Hdl Cholesterol Precipitating ReagentJ.S. Medical Assoc.LBLClass II
K900151Invacare Extended Care Nursing Home BedInvacare GmbHFNLClass II
K900116Deseret Optima Intravascular CatheterDeseret Medical, Inc.FOZClass II
K897194Pharmaseal Epidural Catheter & Continuous EpiduralBaxter Healthcare CorporationBSOClass II
K896874Dantec Electrodes Model Dne 116, 117 & 13P02/12Dantec Medical, Inc.IKTClass II
K896712Pharmaseal Epidural CatheterBaxter Healthcare CorporationBSOClass II
K895460Concentric Electrode Type #13R01, 13R02Dantec Electronics, Inc.IKTClass II
K894241Model 20-Ch W/ Ar-10A/u Optical AttachmentDirected Energy, Inc.GEXClass II
K902083Chrom-Trol Cat. No. 5300 W/ New AnalyteHelena Laboratories, Corp.GJTClass II
K902082Zefazone Susceptibility Test DisksDifco Laboratories, Inc.JTNClass II
K901697Silistor Ceramic and Resin Repair SystemKulzer GmbHEBFClass II
K901681Formasil(r)a Polyvinyl Siloxane LineKulzer GmbHELWClass II
K901414Columnmate (Automated Column System) 1580, 1581Helena Laboratories, Corp.LCPClass II
K901322Dobbhoff(r) Polypectomy SnareBiosearch Medical Products, Inc.FDIClass II
K900547Water Pik(r) W/add'l ClaimsTeledyne Water PikEFSClass I
K900546Bartels Neisseria Gonorrhoeae Direct FluorescentBaxter Healthcare CorporationGTHClass II
K902378Cardiothoracic RulerDevcom, Inc.KPRClass II
K902353Custom Ite Hearing Aid Models F and LOticon, Inc.ESDClass I
K902352Custom Ite Hearing Aid Model: HOticon, Inc.ESDClass I
K902351Custom Ite Hearing Aid Models C and MOticon, Inc.ESDClass I
K901931Leg EezeJereva, Inc.IROClass I
K901508Retrax Safety SyringeRetraxFMFClass II
K901377Barton-Mayo Tracheostoma ButtonMedical Innovations InternationalKACClass I
K901366Invotec Septal ButtonInvotec International, Inc.LFBUnclassified
K901310Ultrastat Nasal CatheterInvotec International, Inc.EMXClass I
K901307Passage Airway SplintInvotec International, Inc.LYAClass I
K901306Invotec Bi-Valve SplintInvotec International, Inc.LYAClass I
K901167(Eyeglass) Frames and SunglassesOptique Marquis, Div. Sugerose, Inc.HQYClass I
K901160Nubaloo(r) SunglassesBlublocker LLCHQYClass I
K900730Arvee Apnea Monitor, Model 4800Arvee Medical, Inc.BZQClass II
K900518Blom-Singer(r) Tracheoesophageal Puncture KitFreudenberg Medical, LLCEWLClass II
K900267Jahn Ventilation TubeSmith & Nephew Richards, Inc.ETDClass II
K900171Expandacel Nasal TamponsSurgitrend, Ltd.EMXClass I
K897091Frame, SpectaclePt Midas Surya Optical Co.HQZClass I
K896634Caraglas Xtra Synthetic Casting TapeBuckman Co., Inc.LGFClass I
K896254Danek Precision Rod SetDanek Medical, Inc.KWPClass II
K902549Titan Gladiator Adjusting TableTitan TablesINQClass I
K902234Titan Apollo and Nova Adjusting TablesTitan TablesINQClass I
K901166Dalton Technology Flexible ScrewdriverDalton Technology, Inc.HXXClass I
K901165Modular Flexible Drilling SystemDalton Technology, Inc.HWEClass I
K902267Blood Gases/pc02, Po2 Analysis ProductsPhoenix Diagnostics, Inc.CHLClass II
K902229Coulter Carbon Dioxide ReagentCoulter Corp.KHSClass II
K902199Coulter Direct BilirubinCoulter Corp.CIGClass II
K902175Coulter Urea Nitrogen ReagentCoulter Corp.CDQClass II
K902173Coulter Serum Iron/uibc ReagentCoulter Corp.JIYClass I
K902155Hi Chem Ise Reagents (Products #88960 and #88964)Hichem DiagnosticsJIMClass II
K902095Blood Gas/electrolyte/co-Oximeter ControlsPhoenix Diagnostics, Inc.JJYClass I