510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3439 of 3526
510(k) clearances, page 3439 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K781076Chemistry AnalyzerJohns Scientific, Inc.JJEClass I
K781075Stattek-Glucose Low LevelBoehringer Mannheim Corp.CGAClass II
K781071Standards, Hormone, Thyroid StimulatingPcl-Ria, Inc.JITClass II
K781069T3 Standards in Human SerumPcl-Ria, Inc.JITClass II
K781062Dropper, Solution Trichrome, Cepti-SealMarion Laboratories, Inc.HYWClass I
K781061Droppers, Solution, IodineMarion Laboratories, Inc.JTSClass I
K781060Monoject Endosseous Dental ImplantSherwood Medical IndustriesDZEClass II
K781059Cutter/compur Mini CentrifugeCutter Laboratories, Inc.GKFClass II
K781056Digital Image Memory/processorQuantex Corp.
K781038Hydraulic Suction Biopsy Pump Model 7MmQuinton, Inc.KNWClass II
K781024Ceruoplasmin Serum Anti-HumanIcl ScientificDDBClass II
K781023Alpha-1-Acid Glycoprotein Serum, Anti-HuIcl ScientificDEXClass I
K781022Anti-Human Ciq SerumIcl ScientificDAKClass II
K781019Surg. Gown & Drape, Low Lint TreatmentKimberly-Clark CorporationKKYClass II
K781017Anti-Human C1 Inhibitor Serum (Goat)Icl ScientificDBAClass II
K781016C3pa (Gbg) Properdin Factor BIcl ScientificJZHClass II
K781015Anti-Human Ldl SerumIcl ScientificDFCClass II
K780972Quickrate Reaction Rate AnalyzerOlympus Corp.JJIClass I
K780951Bio-Monitor GentamicinMonitor Science Corp.DKDClass II
K780950Bio-Monitor TobramycinMonitor Science Corp.DIDClass II
K780949Bio-Monitor AmikacinMonitor Science Corp.KLPClass II
K780934In Vitro Tobramycin Ria KitClinical Assays, Inc.KLBClass II
K780905Limb CoverHydro-Med Products, Inc.IPMClass I
K780889Digoxin Standards in Human SerumPcl-Ria, Inc.DMPClass I
K780877Enema BagAbco Dealers, Inc.FCEClass I
K780869Cell Culture LinesBioassay Systems Research Corp.KIRClass I
K780868Chest RollsDevon Industries, Inc.FSEClass I
K780867Pad Holder KitDevon Industries, Inc.FSEClass I
K780866Chest Rolls HolderDevon Industries, Inc.FSEClass I
K780862Model 290 Oxygen Rich Air Supply UnitThe John Bunn Co.CAWClass II
K780856Barrier Gynecology Pack Fabric 450Surgikos, Inc.KKXClass II
K780853Op-Site Adhesive DrapesAcme United Corp.KKXClass II
K780845Conchaneopak a Cartridge HumidifierRespiratory Care, Inc.BTTClass II
K780844Barrier Obstetrical Pack Fabric 450Surgikos, Inc.KKXClass II
K780843Barrier Abdominal Pack Fabric 450Surgikos, Inc.KKXClass II
K780842Barrier Basic Pack Fabric 450Surgikos, Inc.KKXClass II
K780841Barrier Medium Sheet 450Surgikos, Inc.KKXClass II
K780840Barrier Laparotomy Sheet 450Surgikos, Inc.KKXClass II
K780839Barrier Pediatric/incise Drape 450Surgikos, Inc.KKXClass II
K780784Aspiration NeedleFerris Mfg. Corp.KKXClass II
K780632MaxiceptorMed GeneralISBClass II
K781337Conjugated Bile Acids Ria KitBD Becton Dickinson Vacutainer Systems PreanalyticKWWClass II
K781312Thermometer, Model 49TaYellow Springs Instrument Co., Inc.FLLClass II
K781301Wrap, SterilizationStanford Professional ProductsFRGClass II
K781279Suction CanisterAbco Dealers, Inc.KDQClass II
K781276X-Ray, PortableAir-Shields, Inc.IZLClass II
K781274Gamma Med IIMick Radio-Nuclear Instruments, Inc.JAQClass II
K781246Foam Comfort RingsFibre Formations, Inc.FMPClass I
K781234Tubes, Lukens, TomasLudwig Medical, Inc.KDQClass II
K781216Infusion Controller, ParenteralNational Patent Development Corp.FLSClass II