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 3067 of 3528
510(k) clearances, page 3067 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K842363Penlon Anesthesia Ventilator Series 300Bear Medical Systems, Inc.CBKClass II
K842362Penlon Transport Ventilator Series 350Bear Medical Systems, Inc.CBKClass II
K842325CapnometerSensors, Inc.CCKClass II
K842299Zinc Dust SuspensionIrvine Diagnostic ServicesJSFClass I
K842247Meloy Autoantibody Test SysMeloy Laboratories, Inc.DBMClass II
K842207Wako B.g. Pretest StripsHealthdyne, Inc.CGAClass II
K842079Gastrin 34 Hormone by RadioummunoassayImmuno Nuclear Corp.CGCClass I
K842053Paraplast Extra Tissue Embedding Med.Sherwood Medical Co.KEOClass I
K842017Para 4Streck Laboratories, Inc.JPKClass II
K841774Unimacs, Patent Pending Universal MamTechnical Devices for MedicineIZHClass II
K841231Pulse Generator 688B & 688LSiemens Elema ABDXYClass III
K841228Pulse Generator 718B & 718LSiemens Elema ABDXYClass III
K841226Pulse Generator 728, 728B & 728LSiemens Elema ABDXYClass III
K840972Spirotech St-550Spirotech, Inc.BZGClass II
K842305C.a.p.d. Automatic Heater Pdh 200Medionics International, Inc.FKXClass II
K842298Oxidase Test Strips-OxidasesureIrvine Diagnostic ServicesJSFClass I
K842205Oxy-VacMedi-Tech, Inc.BSYClass I
K842198Amer. Pharmaseal No Touch Satin CathetAmerican Pharmaseal Div. AhscBSYClass I
K842192Croup Tent FrameHome Run Treadmill Co.CCQClass I
K842142Bx-400Bloomex International, Inc.IPFClass II
K842013Sigma Procedure 47-UVSigma Chemical Co.CGSClass II
K842010Thyroxine-Binding Globulin RadioummuNichols Institute DiagnosticsCEEClass II
K841993Hl-1, Defined Serum Free MediaVentrex Laboratories, Inc.KITClass I
K841963Gastrin RiaSyncor Intl. Corp.CGCClass I
K841955Dupont Aca Magnesium CalibratorE.I. Dupont de Nemours & Co., Inc.JISClass II
K841950Pulse Generator Kalos-04Biotronik Sales, Inc.DXYClass III
K841948Testosterone Direct RadioimmunoassaySorin Biomedica, Fiat, USA, Inc.CDZClass I
K841947Estradiol Direct Radioimmunoassay KitSorin Biomedica, Fiat, USA, Inc.CHPClass I
K841930Enzymatic Acetaminophen AssayDiagnostic Chemicals, Ltd. (USA)LKPClass II
K841927T3 UptakeSyncor Intl. Corp.KHQClass II
K841636Neos MBiotronik Sales, Inc.DXYClass III
K841530Double Lumen Sublcavian-FemoralMedical Components, Inc.KNZClass II
K841526Ortho Varicella-Zoster Virus Ident.Ortho Diagnostic Systems, Inc.GQXClass II
K841437Pennsylvania Hospital Hip SysZimmer GmbHKWLClass II
K841229Pulse Generator 698, 698B & 698LSiemens Elema ABDXYClass III
K841022Src Total KneeJoint Medical Products Corp.
K840462Vitamin B12 57Co/folate 125I -Corning Medical & ScientificCDDClass II
K832705UltramaxMedicorp, Inc.LIFClass II
K831830Lyris Modular Info SystemBiovation, Inc.JQPClass I
K842309Vitacomm 100 Esophageal StethoscopeVitacomm, Inc.BZTClass II
K842300Onpg DisksIrvine Diagnostic ServicesJSFClass I
K842297Arginie BrothRemel Co.JSFClass I
K842296Isostation Lower Back MachineIsotechnologies, Inc.IKKClass II
K842291Spot Test Catalase TestDifco Laboratories, Inc.JSFClass I
K842290Spot Test Ninhydrin ReagentsDifco Laboratories, Inc.JSFClass I
K842232Plain Jane Series WheelchairInvacare GmbHIORClass I
K842183Adp Ana Ifa TestApple Diagnostic ProductsDHNClass II
K842056Elvi 165 Proteo SeroskopLogos Scientific, Inc.JQTClass I
K842025Ion 4 Sodium/potassium/chloride/totalHi Chem, Inc.JGSClass II
K842019Tibc Pretreatment KitE.I. Dupont de Nemours & Co., Inc.JQEClass I