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 2054 of 3531
510(k) clearances, page 2054 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K936251Coxsackievirus B3 Monoclonal AntibodyLight DiagnosticsGNMClass I
K936145Coxsackievirus B1 Monoclonal AntibodyChemicon Intl., Inc.GNMClass I
K936089Coxsackie A24 Virus Monoclonal AntibodyChemicon Intl., Inc.GNMClass I
K936073Enterovirus Monocl Antibody Det of Coxsackie A9 VirusChemicon Intl., Inc.GNMClass I
K935890Zetaplus (Putty)Zhermack Dental ProductionELWClass II
K924387Instent Endocoil Biliary EndoprosthesisInstent, Inc.FGEClass II
K953859Bond-It Dual Cure ActivatorJeneric/Pentron, Inc.KLEClass II
K953592Revolution BondE&D Dental Products, Inc.KLEClass II
K953507Type 1 & 2 (Humidair I & II)Icor ABBYDClass I
K953231Ppmi-(Xxx) and Ppmo-(Xxx)Patriot Products, Inc.FPAClass II
K952101Marquette Defib ElectrodesMarquette Electronics, Inc.MKJClass III
K951250Karl Storz Suction CathetersKarl Storz Endoscopy-America, Inc.HETClass II
K945246Preventor and Protector Latex CondomsAmerican Pharmaceutical Co., Inc.HISClass II
K944362Heartcard Cardiac Event MonitorInstromedix, Inc.DXHClass II
K944133Mtb 1043 Treatment BoothMark Solutions, Inc.LGMClass II
K953863Hichem Ise Standards Kit 70011Hichem DiagnosticsJIXClass II
K953862Hichem Isekci Solution Kit 70010Hichem DiagnosticsCGZClass II
K953861Hichem Ise Intdernal Reference Kit 70009Hichem DiagnosticsCGZClass II
K953860Hichem Ise Diluent Kit 70008Hichem DiagnosticsCGZClass II
K953849Prism ElectroscopeKarl Storz Endoscopy-America, Inc.EOXClass II
K953725Cronex Radiation Therapy Verification CassetteE.I. Dupont de Nemours & Co., Inc.IXAClass II
K953724Cronex Radiation Therapy CassetteE.I. Dupont de Nemours & Co., Inc.IXAClass II
K953370Karl Storz ENT ShaverKarl Storz Endoscopy-America, Inc.EQJClass I
K952949Acetaminophen AssaySekisui Diagnostics P.E.I. Inc.LDPClass II
K952919Urinary Metanephrine KitBioanalytical Systems, Inc.CHQClass I
K952778CheshirePerceptive Systems, Inc.LLZClass II
K952086Tropicair Convective Warming BlanketsSeabrook Medical Systems, Inc.DWJClass II
K9520373 Lpm Oxygen ConcentratorDevilbiss Health Care, Inc.CAWClass II
K951750Glucose Test Item Number 97375/94EMD Millipore CorporationLFRClass II
K951671Osteonics Restoration Monolithic II Slotted Hip Stem SeriesOsteonics Corp.MEHClass II
K950881Phaco TipAmerican Optical Corp.HQCClass II
K950476Disposable ECG Monitoring Electrode #4440 60Mm, #4420 40MmNikomed U.S.A., Inc.DRXClass II
K950377Parker Model PeParker Treadmill Co., Inc.IOLClass I
K950376Parker Model PmParker Treadmill Co., Inc.IOLClass I
K950359Konica Laser Imager Li-21Storch Amini & Munves PCLMCClass II
K946196Tropicair Convective Waring SystemSeabrook Medical Systems, Inc.DWJClass II
K953594VulcanCmp Industries, LLCEJHClass II
K953526SeekUltradent Products Inc.LFCClass II
K953380Laboratory SuppliesSteri-Oss, Inc.DZEClass II
K953251Mertex-Plus O.r./surgeons GownMercana Industries, Ltd.FYAClass II
K953192Model A15-103Beaverstate Dental, Inc.EAYClass I
K953191Model A15-101Beaverstate Dental, Inc.EAYClass I
K952858Light-CureMidwest Orthodontic Mfg.DYHClass II
K952857Pro-LockMidwest Orthodontic Mfg.DYHClass II
K952833AmpriAmpri Rubberware Industries Sdn BhdLYYClass I
K952637Qualicheck 4 GlucoseRadiometer America, IncJJSClass I
K952560Sonoclot Coagulation & Platelet Function AnalyzerSienco, Inc.JPAClass II
K952307BioscanBiosys Laboratories, Inc.JILClass II
K952116Cover GownAmerican Threshold Industries, Inc.FYCClass II
K951708Elsa-HctCis-Us, Inc.JKRClass II