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 3052 of 3529
510(k) clearances, page 3052 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K841517Cloutier II Total Knee W/beaded SurfZimmer GmbH
K840152Ferris Vent-a-DermFerris Mfg. Corp.
K843161Emit 700 Control Set aSyva Co.DIFClass I
K843160Emit 700 Cocaine Metabolite AssaySyva Co.DIOClass II
K843152Systemate Calcium 67214Em Diagnostic Systems, Inc.CICClass II
K843089Medtronic 8437/8438Medtronic, Inc.DXYClass III
K843088Eba 3 S CentrifugeBoehringer Mannheim Corp.JQCClass I
K843087Universal 2 S CentrifugeBoehringer Mannheim Corp.JQCClass I
K842970Allergentics Total Ige/theophyllineAllergeneticsJJYClass I
K842968Chad Adjustable CannulaChad Therapeutics, Inc.CATClass I
K842876Portable Lifecare Ventilator Plv-102Lifecare Services, Inc.CBKClass II
K842713Tdx DisopyramideAbbott MedicalLBZClass II
K843086Dulbecco's Modified Eagle's Nutirent MixSigma Chemical Co.KITClass I
K843085Rpmi-1640 Medium #R3505 W/hat, L-GlutaSigma Chemical Co.KITClass I
K842969Allergenetics Aller-Specific Ige SerumAllergeneticsDGPClass II
K842940Cba FormalinAnatech, Ltd.IFPClass I
K842862Cb FormalinAnatech, Ltd.IGEClass I
K842834Hep-2 CellsBartels Immunodiagnostic Supplies, Inc.KJRClass I
K842833Pmk Primary Monkey Kidney-CellsBartels Immunodiagnostic Supplies, Inc.KJRClass I
K842749Fiax Total Ige Test KitIntl. Diagnostic TechnologyDGPClass II
K842664Anti-Toxoplasma Gondii KitAmico Lab, Inc.GLZClass II
K842526Amizyme-Leishmania Spp. Test KitAmico Lab, Inc.LOOClass I
K842470Tissue-Tek Immunohistology Kit LysozzmMiles Laboratories, Inc.DFHClass II
K842468Tissue-Tek Immunohistology Kit Iga/iggMiles Laboratories, Inc.CZPClass II
K841502Lifescope 6 Oec-6105Nihon Kohden America IncDRTClass II
K841501Lifescope 6 Oec-6102Nihon Kohden America IncDRTClass II
K841500Lifescope 6 Oec-6201Nihon Kohden America IncDSIClass II
K841499Lifescope IINihon Kohden America IncDRTClass II
K843176Kodak X-Omatic Radiation Therapy CassEastman Kodak CompanyIXAClass II
K843151Systemate Glucose 67215Em Diagnostic Systems, Inc.CGAClass II
K843150Systemate Glucose 67216Em Diagnostic Systems, Inc.CFRClass II
K843149Kodak T-Mat C Film So-119Eastman Kodak CompanyLWZClass III
K843148Kodak T-Mat H Film So-118Eastman Kodak CompanyLWZClass III
K843108Systemate AlbuminEm Diagnostic Systems, Inc.CIXClass II
K843107Systemate Total Protein 67218Em Diagnostic Systems, Inc.CEKClass II
K843106Systemate Triglyceride 67219Em Diagnostic Systems, Inc.CDTClass I
K843105Systemate Creatinine 67223Em Diagnostic Systems, Inc.CGXClass II
K843057Urea Assay KitDiagnostic Chemicals, Ltd. (USA)CDQClass II
K843031Magnesium Assay KitDiagnostic Chemicals, Ltd. (USA)JGJClass I
K843030Inorganic Phosphorus Assay KitDiagnostic Chemicals, Ltd. (USA)CEOClass I
K843029High Density Lipoprotein PrecipitatinDiagnostic Chemicals, Ltd. (USA)LBSClass I
K843028Total Protein Assay KitDiagnostic Chemicals, Ltd. (USA)CEKClass II
K842997Laser Rectoscope Set 784Laser Industries, Ltd.FDCClass II
K842895Wba - I.r.i.s.Siemens Gammasonics, Inc.JAMClass I
K842894Kemble 405Kemble Instruments, Inc.JQWClass I
K842889Argyle Custom Tubing PackSherwood Medical Co.DWFClass II
K842831Baim Coronary Sinus Flow CalculatorElectro-Catheter Corp.DXGClass II
K842667External Pediatric Defibrillator PaddleMarquette Electronics, Inc.LDDClass II
K842645Cardiac Supply TrayDeRoyal Industries, Inc.DQYClass II
K842620Cardiotomy Reservoir W/filter Bcr-3500American BentleyDTNClass II