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 3300 of 3528
510(k) clearances, page 3300 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K810917Kova Trol I Human Urine (Dried)Icl ScientificJJWClass I
K810906Tri-Level Ndi ControlNuclear Diagnostics, Inc.JJYClass I
K810905Isomune-CkHoffmann-La Roche, Inc.JHWClass II
K810904Bovine Calf SerumBiolabs, Inc.KISClass I
K810903Newborn Bovine SerumBiolabs, Inc.KISClass I
K810901Insulative Coating for Card. Pulse GenIntermedics, Inc.DXYClass III
K810891Coat-a-Count Cortisol Ria KitSiemens Healthcare Diagnostics Inc.CGRClass II
K810870Gemeni Ck-Mb Isoenzyme Abnormal SerumGemini, Inc.JJTClass I
K810867Follicle Stimulating Hormone (Fsh)Pcl-Ria, Inc.JISClass II
K810863Kallestad Hep-2 Cell Line SubstrateKallestad Laboratories, Inc.DBMClass II
K810861Creatine Kinase Mb Isoenzyme Immuno UVThe Dow Chemical Co.JHWClass II
K810830Hoyt Cotton RollsHoyt LaboratoriesEFNClass I
K810825Polyvinyl Silicone Impression MaterialDental-Material GesellschaftELWClass II
K810819Medi/nuclear #Xe-102 Xenon/masterMedi Nuclear Corp., Inc.IYTClass II
K810813Dmg-Polishable CompositeDental-Material GesellschaftEBDClass II
K810805Water Pik Automatic ToothbrushTeledyne, Inc.JEQClass I
K810797Low Dose ServochestPhilips North America LLCKPRClass II
K810789Gdc-1054Deringer-Ney, Inc.EJTClass II
K810760Gill's Hematoxylin #3Surgipath
K810759Gill's Hematoxylin #2SurgipathHYJClass I
K810758Gill's Hematoxylin #1SurgipathHYJClass I
K810733Harris HematoxylinSurgipathHYKClass I
K810706Exmoor Aural Grommet Ag/t5Exmoor Plastics LimitedETDClass II
K810705Exmoor Aural Grommet Ag/t4Exmoor Plastics LimitedETDClass II
K810704Exmoor Aural Grommet Ag/t3Exmoor Plastics LimitedETDClass II
K810703Exmoor Aural Grommet Ag/t2Exmoor Plastics LimitedETDClass II
K810702Exmoor Aural Grommet Ag/t2lExmoor Plastics LimitedETDClass II
K810701Exmoor Aural GrommetExmoor Plastics LimitedETDClass II
K810687Sr-IvocapJ. Aderer, Inc.EBIClass II
K810686Sr-IvolenJ. Aderer, Inc.EBHClass I
K810666Braun TravelGilette Medical Eval. LaboratoryJEQClass I
K810656Sr-Ivoseal(soft Relining)J. Aderer, Inc.
K810604Electrode/pacer System Analyzer PMA 400Telectronics, Inc.DTCClass II
K810603Implantable Programmable Cardiac PulseTelectronics, Inc.DXYClass III
K810523Sr-IvosealJ. Aderer, Inc.ELWClass II
K810350ThromboplastinPacific HemostasisGJSClass II
K801181Vap 2001Blendette Intl., Ltd.
K810859Single Use Seldinger/cournand Perc. NdlProcedure Products, Inc.DREClass II
K810828Non-Invasive AmplifierHenry Ford HospitalDRRClass II
K810814Thermometer, Electronic ClinicalHer-Mar, Inc.FLLClass II
K810785Skin Staple RemoverRowley Mfg. Co.KDCClass I
K810751Pds Cardiac Calc. Softw. Progr. #A3604afGeneral Electric Co.BZCClass II
K810700Chromops Fm-100 Color Vision TesterVisidyne Corp.HITClass I
K810698PharmalogCircadian, Inc.DSHClass II
K810598X-Ray Collimating DevicesMidmark CorpIZWClass II
K810590P.r.m. 80T.E.M. Instruments, Ltd.IZWClass II
K810589Neuro-EcatEg&G Ortec, Inc.KPSClass II
K810588Synchronizer #208Brattle Instrument Corp.IXOClass I
K810561Dopscan Model 1050Carolina Medical ElectronicsDPWClass II
K810862Crp SlideSyn-Kit, Inc.DCNClass II