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 3170 of 3528
510(k) clearances, page 3170 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830469Bilirubin Standard-LyophilizedDow Instruments & Reagents, Inc.JITClass II
K830462Abuscreen Radioummunoassay--UrineHoffmann-La Roche, Inc.DOEClass II
K830461Abuscreen Radioummunoassay-MethaqualoneHoffmann-La Roche, Inc.KXSClass II
K830460Abuscreen Radioimmunoassay for MorphineHoffmann-La Roche, Inc.DOEClass II
K830447Kinetic CreatinineAmerican Monitor Corp.CGXClass II
K830446Oxygen Monitor Ohio 5100Airco/Ohio Medical ProductsCCLClass II
K830433Patient Monitor 575Kone Instruments, Inc.DRTClass II
K830432Central Station 590Kone Instruments, Inc.DRTClass II
K830417Respi-Neb-Aerosol SystemProfessional Medical Supply, Inc.BTIClass II
K830414Titanaloy Submersible Implant SystemBoehringer/Miter, Inc.DZEClass II
K830407EclipseDiagnostic Medical InstrumentsDSIClass II
K830390Implantable Bipolar Cardiac Pulse GenTelectronics, Inc.DXYClass III
K830381Sterile Safety PinsDevon Industries, Inc.GAZClass II
K830378Sterile, Disposable, Hypodermic NeedlesAbco Dealers, Inc.GAAClass I
K830363Bactec 170 Tryptic Soy Broth W/resinsBD Becton Dickinson Vacutainer Systems PreanalyticLJFClass I
K830327Dosimetric Release of Radiation DevAmerican BentleyDTZClass II
K830316UniflexBuckman ConsultantsBXBClass I
K830295Medilog 9000 SystemOxford Medilog, Inc.GWQClass II
K830263Floret Nasal TamponRitmed, Inc.LYAClass I
K830236Rionet Hearing AidRion Acoustic Instruments, Inc.ESDClass I
K830211Api Tb-Ident*Analytical Products, Inc.JSYClass I
K830189Cardiovascular Saw BladesTemp Medical Products, Inc.DWHClass I
K830111SeptocalNorth Pacific Dental, Inc.
K823905Surgical BladesDesigns in MedicineGEIClass II
K823878Implantable Pacemaker Pulse Gen, Models 241 & 242Pacesetter SystemsDXYClass III
K823764Scanlan Single-Use Aorta PunchScanlan Intl., Inc.DWSClass I
K823754Sahota-Kaplan HemostatErickson Industries, Inc.DQOClass II
K823592Phadebas & Phadezym Rast Test AllergPharmacia, Inc.DHBClass II
K823581Elpha 500Prothia USA, Inc.GCJClass II
K823334Physiological Press. Transducer Pcm3630PsitronDRSClass II
K822873DevethermEko Scann ABDQBClass II
K822842Ambulatory Mark IWindsor Medical, Inc.FRNClass II
K837142Transducers Models 421, 419 and 420 for Irex SystemHoffrel Instruments, Inc.
K837178Standex SystemElscint, Inc.
K837152Therac 25 Linear AcceleratorAtomic Energy of CanadaJAIClass II
K837151Blue Green Filter System to Model 152 and 150 Laser SystemBritt Corp., Inc.
K837109UnknownElder Pharmaceuticals, Inc.
K837108Ultraviolet Elder Psoralite Series 3000 UvaElder Pharmaceuticals, Inc.
K837106Elder Psoralite Series 2000 Uva Irradiation SystemElder Pharmaceuticals, Inc.
K8370972D Cardiac Sector ScannerSecond Foundation, Inc.
K837029Echosine 1000, Pulsed a-Mode Ultrasound DeviceAmerican Electromedics Corp.
K830207Raichem Hdl-Cholesterol ReagentReagents Applications, Inc.LBRClass I
K837183Hi-Lo Radiological StretcherElscint, Inc.
K837182Tomax Ls-20Elscint, Inc.
K837180Trephix Three Phse Generators and Exonon Single Phase GeneratorsElscint, Inc.
K837179Taurus Ls Three-Phase GeneratorsElscint, Inc.
K837177Controllex Ls-5Elscint, Inc.
K837176Exor Ls-24Elscint, Inc.
K837175Armex Ls-51Elscint, Inc.
K837171Ultrasonic EchoscopeAusonics Pty, Ltd.