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 3166 of 3528
510(k) clearances, page 3166 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830680Air-Shields Ventimeter Ventilator-ContrNarco ScientificBSZClass II
K830669Fiax Complement C4 Test KitIntl. Diagnostic TechnologyDBIClass II
K830653Polystyrene Microtiter Plate ImmunosorbDiagnostic Reagent Tech.DGOClass II
K830618Breathing FilterOhio Medical ProductsCAHClass II
K830569Cynox I HemoglobinometerBuffalo Medical Specialties Mfg., Inc.JJQClass I
K830372Artimicrobial Removal DeviceMarion Laboratories, Inc.LJFClass I
K830180Referee Brand Co-Oximeter ReagentsAnalytical Products, Inc.KHGClass II
K823521Sterile Hd Cvp TrayBill Dude Hospital Disposables, Inc.FMFClass II
K830905Lundia 10-2-N Parallel Flow DialyzerGambro, Inc.KOCClass II
K830901Connector 5 in 1, T-ConnectorMedical Specialists in PackagingGAZClass II
K830878Binocular LoupeAlmore Intl., Inc.HJHClass I
K830840Open Ended Ureteral CatheterVan-Tec, Inc.GBMClass II
K830839Amer. 400 Series Temp. Probes-RectallAmerican Pharmaseal Div. AhscFLLClass II
K830835Sterile 5 in 1 ConnectorsAbco Dealers, Inc.GAZClass II
K830822Eye DrapeCooperVision, Inc.HMTClass II
K830819Modification Electronic Clinical Thermo-Mon-A-Therm, Inc.FLLClass II
K830814Point, Paper EndodonticEndodent, Inc.KJJUnclassified
K830777Electric Mouth MirrorAlmore Intl., Inc.EAXClass I
K830774Binocular Magnifier 2XAlmore Intl., Inc.HKCClass I
K830751Kemtek 102Kemble Instruments, Inc.JJJClass I
K830714Total Bilirubin ReagentHi Chem, Inc.CIGClass II
K830700Mmh Pth Ria KitDiagnostic SystemsCEWClass II
K830683Tdx ThyroxineAbbott MedicalKLIClass II
K830679Uric Acid Colorimetric DeterminationDow Instruments & Reagents, Inc.KNKClass I
K830629Cobe Rx MeterCobe Laboratories, Inc.FLBClass II
K830593Ensure DressingWarner-Lambert Co.NADClass I
K830553Dental Porcelain PowderDentsply Intl.EIHClass II
K830530Temp TraceProgress Mankind TechnologyFLLClass II
K830421Syn-02 Pn AmplifierBiosearch Medical Products, Inc.FFXClass II
K830394Providone-Iodine Prep-Pads & TowelettesH & P Industries, Inc.GECClass I
K830393Providone-Iodine SwabsticksH & P Industries, Inc.GECClass I
K830353Esophageal Probe W/temp. IndicatorScience Development Corp.FLLClass II
K830304Replam HydroxyapatiteReplam Corp.LYCClass II
K830262Floret Ophthalmic Eye SpearRitmed, Inc.HOZClass II
K830044Odontic Centric(bite) Regist. PasteWallace A. Erickson & Co.ELWClass II
K830037Extension Handle for Acutome ProbePrecision Medical Instruments, Inc.HQEClass II
K823586Computer-Aided Electrocardiograph Fcp200Brentwood Instruments, Inc.DSIClass II
K823585Computer-Aided Electrocardiograph Fcp-13Brentwood Instruments, Inc.DSIClass II
K823537Glucose ReagentAc Biochemical Laboratories, Inc.FMFClass II
K823088AspitronIntl. Ophthalmic Industries Corp.HQCClass II
K830910Manometer Set C.v.p. #S 298/299Exco, Inc.KRKClass II
K830855Sesam Treatment TableLic-OrthionINQClass I
K830854Collapsable Lavatory Seat HeightenerLic-OrthionILCClass I
K830852Shower Stool W/handlesLic-OrthionILSClass I
K830851Bath Tub Seat & Bath BoardLic-OrthionILCClass I
K830850Ob Tripp Transport ChairLic-OrthionINMClass I
K830849Ob TiltLic-OrthionINQClass I
K830848Resi-WalkerLic-OrthionITJClass I
K830842Ob Help ArmLic-OrthionILEClass I
K830798Sterile Surgical Pain Relief ElectrodeLectec Corp.GXYClass II