510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 2061 of 3531
510(k) clearances, page 2061 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K952395Redi Nurse System (Rns) Sterile Water for IrrigationContour Fabricators of Florida, Inc.BSYClass I
K952363Opus Pacemakers (Models 4021, 4033, and 4034)Ela Medical, Inc.ELAClass I
K952222Nellcor N-20Pa Portable Pulse OximeterNellcor, Inc.DQAClass II
K952208Prosys Leg BagConvatec, A Division of E.R. Squibb & SonsKNXClass II
K951344Rmi HemoconcentratorResearch Medical, Inc.KDIClass II
K950647Ultracell Neuro SpongesUltracell Medical Technologies, Inc.HBAClass II
K950389Sorba Model Cic-1000 Non-Invasive Hemodynamic MonitorSorba Medical Systems, Inc.DSBClass II
K950227Rubelisa (Rubestat)Bio-Whittaker, Inc., A Cambrex Co.LFXClass II
K950093Amd System Working Channel Scope and AccessoriesSmith & Nephew Richards, Inc.HRXClass II
K945429Spacelabs Medical Expansion Module (Model 90352)GE HealthcareDSIClass II
K943861Capiox Sp Pump HeadTerumo Corp.KFMClass II
K943801Uriglow Transilluminating Ureteric Stent ModelRocket of London, Ltd.FCSClass II
K942353Centurion Umbilical CatheterCenturion Medical Products, LPFOSClass II
K933847Hys-Surgiflator VpNovanta Medical GmbHHIGClass II
K932333Protectoral Ultrasonic Handpiece ProcessorGull Laboratories, Inc.EFBClass I
K953066Serodia AtgFujirebio America, Inc.DDCClass II
K952894Visulink 900 ArgonCarl Zeiss, Inc.HQFClass II
K952789Opticlone Cd4fitc/cd8 Pe Monoclonal AntibodiesIMMUNOTECH s.r.o.GKZClass II
K952698Endocare Electrosurgical HandpieceCytocare, Inc.GEIClass II
K952590Royal Shield Non-Sterile Pink Coloered, Strawberry Scented Latex Examination GlovesShield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.LYYClass I
K952547Coversan, IslesanMedical Device Development Co.KMFClass I
K952526Cutinova CavityBeiersdorf, Inc.KMFClass I
K952360Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-Mb/myoglobinPrinceton BioMeditech Corp.DDRClass II
K952197Glovetex (Multiple)Pt Mbf Buana MulticorporaLYYClass I
K952110Elmed Thermo-FluxElmed, Inc.GEIClass II
K952041Bodyflex MassagerTruro'S Ent.ISAClass I
K951801Ming-Ya Optical Industrialco., Ltd.Min-Ya Optical Industrial Co., Ltd.HQYClass I
K946186Chal-2500Hogan & HartsonIPFClass II
K945571Abbott Test Pack Strep a TestAbbott MedicalGTZClass I
K944321S-Rom Noiles Posterior Stabilized Total Knee System IIJoint Medical Products Corp.JWHClass II
K943778Osteonics Restoration Cemented Hip Stem SeriesOsteonics Corp.KWLClass II
K943185Bx-200 ScBloomex International, Inc.IPFClass II
K942195Bx-400SBloomex International, Inc.IPFClass II
K941862Inteq Tfcc Repair SystemLinvatec CorporationHRXClass II
K941084SunglassesBlue Gem Sunglasses, Inc.HQYClass I
K936307Dyna-Lok Anterior Plating SystemDanek Group, Inc.MNHClass II
K933882Osteonics Ps Hemi-Hip Stem SeriesOsteonics Corp.LPHClass II
K953561Preperitoneal Distention Balloon Systems (Modification)Origin Medsystems, Inc.GCJClass II
K953457Jedmed Spectrum ENT CabinetJEDMED Instrument CompanyETFClass I
K953424Eclipse 3200CardiogenesGEXClass II
K953402Universix 190Philips North America LLCIXYClass I
K953336Vrs 3 Wall StandPhilips North America LLCIXYClass I
K953295Anesthesia Face MaskMallinckrodt MedicalBSJClass I
K953011Formulation Hws-64 Epa Reg. No. 47371-131Huntington Laboratories, Inc.LRJClass I
K953010Formulation Hws-256 Epa Reg. No. 47371-129Huntington Laboratories, Inc.LRJClass I
K953009Formulation Hws-128 Epa Reg. No. 47371-130Huntington Laboratories, Inc.LRJClass I
K952971Dia Screen Reagent StripsGenesis Labs, Inc.JILClass II
K952851SafeskinSafeskin Corp.LYYClass I
K952793SafeskinSafeskin Corp.LYYClass I
K952745Creatine Kinase Reagent SystemMedical Diagnostic Technologies, Inc.CGSClass II