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 2553 of 3530
510(k) clearances, page 2553 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K900571Amresco Product Number 7728 (Bilirubin Dpd)American Research Products Co.CIGClass II
K900457Cuffed Linder Nasotracheal AirwayPolamedco, Inc.BTRClass II
K900393Opaque PorcelainDentsply Intl.EIHClass II
K900370One/circ (Circumcision Clamp)Bionix Development Corp.HFXClass II
K900354Toxo Igg Elisa TestGull Laboratories, Inc.LGDClass II
K900333E5280 Combined Transcutaneous Tcp02/tcpco2 Elect.Radiometer America, IncLKDClass II
K900316Modified Ham's F-10 Medium and Medium-HepesIrvine Scientific LLCHDRClass II
K900276Exact One(tm) Hematology AnalyzerExact Science, Inc.GKZClass II
K900128Cl-Ope Contact Laser SystemLca, Inc.GEXClass II
K900069Modified Pgl Absorbable Staple*United States Surgical, A Division of Tyco HealthcGDGClass I
K897050Wilson-Cook Lung Biopsy NeedleWilson-Cook Medical Inc.GAAClass I
K896684Kemble Liquid Handling System DispenserSchiff & Co.JQWClass I
K896492Accuprobe Mycobacterium Gordonae Culture TestHologic, Inc.LQFClass I
K896442Ppg Biomedical Ventilator Model IrisaPpg Industries, Inc.CBKClass II
K896404Titamed Antwerp SystemOptikJEYClass II
K896263RhinomanometerJEDMED Instrument CompanyBXQClass II
K896147Biopsy Forcep (Non-Electric)Portlyn Corp.FCLClass I
K896139Sr-IvosealIvoclar North America, Inc.EBIClass II
K896130Sr-IvocapIvoclar North America, Inc.EBIClass II
K896129Urinary Leg BagCypress Medical Products LLCFAQClass I
K895843Ahac Ite Model EntendreAroostook Hearing AidESDClass I
K895386GlasionScientific Pharmaceuticals, Inc.EMAClass II
K894215Evolution UltrasonicMedical Industries America, Inc.CCQClass I
K894090Patient Examin Gloves(mfg: Shanghai Factory)Everbest Machinery (U.S.A.) Co., Ltd.LYYClass I
K881431Siemens Stereodynator 828Elmed, Inc.IPFClass II
K901541Laser Laparoscopic CholecystectomySurgical Laser Technologies, Inc.GEXClass II
K901386Sears Model Ls9093 in-the-Ear Hearing InstrumentMiracle-Ear, Inc.ESDClass I
K901021F300 Series Contact Fiber HandpiecesHgm Medical Laser Systems, Inc.GEXClass II
K900862Dahlberg Model Jm in-the-Ear Hearing InstrumentMiracle-Ear, Inc.ESDClass I
K900848Enema Kit 'Straight' DesignCustom Medical Products, Ltd.FCEClass I
K900847Enema Kit 'Y' DesignCustom Medical Products, Ltd.FCEClass I
K900690Clearfil Veneer Bond KitKuraray Co.EBFClass II
K900447Duoderm* Adhesive Compression BandageConvatec, A Division of E.R. Squibb & SonsKGXClass I
K900308Sperm Select SystemPharmacia, Inc.HDRClass II
K896710Midimate 622Madsen North America, Inc.EWOClass II
K896531NovadermSyncare Corp.KMFClass I
K896248Innovations Nasal TamponInnovations by Necessity, Inc.EMXClass I
K895633Myotrace 10 Biofeedback DeviceNoraxon USA, Inc.HCCClass II
K895174Union Broach Bleaching LightUnion Broach, Div. Moyco Industries, Inc.EEGClass I
K890532Eup-C321 5.0Mhz Convex Type ProbeHitachi Medical Corp. of AmericaITXClass II
K890531Eup-F124 5.0 Mhz Convex Array Finger Top ProbeHitachi Medical Corp. of AmericaITXClass II
K884644Addit. Trans. Eup-B31/033j/v33/u33/032t/l33/u322Hitachi Medical Corp. of AmericaIYOClass II
K901453Quik-Sep(r) Igm Rprotein G Affinity MethodIsolab, Inc.DFTClass II
K901137Chem 1 Clinical Analyzer (Urine Inorganic Phospho)Technicon Instruments Corp.CEOClass I
K900706Modified Accufluor Theophylline Reagent & CalibraInnotron of Oregon, Inc.LGSClass II
K900705Modified Accufluor Quinidine Reagent & CalibratorInnotron of Oregon, Inc.LBZClass II
K900704Modified Accufluor Phenobarbital Reagent & CalibraInnotron of Oregon, Inc.LGQClass II
K900703Modified Accufluor Gentamicin Reagent & CalibratorInnotron of Oregon, Inc.LCDClass II
K900702Modified Accufluor Carbamazepine Reagent & CalibraInnotron of Oregon, Inc.LGIClass II
K900303ConnectParkell, Inc.EMAClass II