510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2880 of 3529
510(k) clearances, page 2880 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K854845Intervascularochsner 50 and Ochsner 500 VascularIntervascular, Inc.DSYClass II
K862939Orchard Grass Allergen DiscImmuno Nuclear Corp.DHBClass II
K862938June Grass Allergen DiscImmuno Nuclear Corp.DHBClass II
K862870Resistal PDegussa Dental, Inc.EJHClass II
K862821Cappel Diagnostics Ana KitCappel Diagnostics, Inc.DHNClass II
K862807Treace Drill SystemTreace Medical, Inc.ERLClass II
K862770Audiometer/master Hearing Aid Mf6Maico Hearing Instruments, Inc.EWOClass II
K862680Modified Regular Maxithins Pads, UnscentedTambrands Inc.HHDClass I
K862679Modified Super Maxithins Pads, UnscentedTambrands Inc.HHDClass I
K862678Modified Regular Deodorant Maxithins PadsTambrands Inc.HHLClass II
K862677Modified Maxithins Panty Shields UnscentedTambrands Inc.HHDClass I
K862676Modified Super Deodorant Maxithins PadsTambrands Inc.HHLClass II
K862674Photon Elite/automated Random Access Im/ch SystemHybritech, Inc.JZTClass I
K862324Osteograf/ar and Osteograf/ar+Coors Biomedical Co.LYCClass II
K862265Cottonwood Allergen DiscImmuno Nuclear Corp.DHBClass II
K862176Russian Thistle Allergen DiscImmuno Nuclear Corp.DHBClass II
K862026Ha-2000 Real Ear SpectroscopeAnd/Or Corp.ETWClass II
K862954Laser Plume FiltersLifestream Int'L, Inc.
K862936Newman Cannulae System (Ncs)Byron MedicalGEAClass I
K862925Heffington Knee RestLex-Ton OrthopedicsINWClass I
K862922Micro-Aire Cast Cutter BladesMicro-Aire Surgical Instruments, Inc.
K862892Caster CarMednet, Inc.IORClass I
K862887Upholstered Bucket SeatMednet, Inc.KNNClass I
K862885Car SeatMednet, Inc.INNClass I
K862883Orthopedic SeatsMednet, Inc.INNClass I
K862800Smx GeneratorGeneral Electric Co.IZOClass I
K862569Heavy Duty (Hd) Suction Units (W/cannulas)JEDMED Instrument CompanyBTAClass II
K862130Comfort-Set* i.v. Catheter Placement Unit.Menlo Care, Inc.FOZClass II
K862124Polymed Laboratories All Silicone Foley CatheterPolymed LaboratoriesKODClass II
K862091Mcgaw Nutra-Feed Efs Enteral Feeding TubeKendall Mcgaw Laboratories, Inc.KNTClass II
K861955Contact TipsCooper Lasersonics, Inc.LNKClass II
K861119Wallant Neurologix Dual Pur Nerve/neuromuscu StimuWallant Intl. Trade, Inc.GZJClass II
K860473Differential Stethoscope W/dual Heads; StereoscopeSchering Corp.LDEClass I
K855127Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc.DXNClass II
K854664Meb-5200Nihon Kohden America IncIKTClass II
K862895TricyclesMednet, Inc.IKXClass I
K862894SchooltableMednet, Inc.INWClass I
K862893Ventral Standing UnitMednet, Inc.
K862890Toilet/shower ChairMednet, Inc.IORClass I
K862889Kiro, Wheelchair for ChildrenMednet, Inc.IORClass I
K862888Perambulator (Stroller)Mednet, Inc.LBEClass I
K862886Kooychair (Pediatric)Mednet, Inc.INMClass I
K862769Faceplate, Custom in-the-Ear Hearing Aid, FprMaico Hearing Instruments, Inc.LRBClass I
K862768Faceplate, Custom in-the-Ear Hearing Aid, Mca10Maico Hearing Instruments, Inc.LRBClass I
K862605Modular Mass Spectrometer (M.s.)Revvity Health Sciences, Inc.CCKClass II
K862181Meconium Suction TrapMichael Reese Hospital and Medical CenterBSYClass I
K862944Kodak Cft Film So-141Eastman Kodak CompanyIWZClass I
K862912Renamelize Polishing PasteCosmedent, Inc.EJRClass I
K862851Almore Face MaskAlmore Intl., Inc.
K862832Model 303-42/303-43 Aspartate Aminotransferase KitDiagnostic Chemicals, Ltd. (USA)CITClass II