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 3127 of 3528
510(k) clearances, page 3127 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K832926Enzymatic Glucose DeterminationSeragen Diagnostics, Inc.CGAClass II
K832892Modified Chorio-ShureNuclear Medical Laboratories, Inc.JHIClass II
K832879B-Slide Pregnate Pregnancy Test KitFisher Scientific Company L.L.C.JHJClass II
K832851Agar 8000 TENSKimed Industries, Inc.GZJClass II
K832771Erythrocyte TestBio-Analytics Laboratories, Inc.LKZClass II
K832714Verimed MyoexorciserVerimed Holdings, Inc.HCCClass II
K832356Portable Operat. Rm. Monitors Hs30/40Medtel Pty., Ltd.BZNClass I
K832355Crash CartQuinton, Inc.BZNClass I
K832264Fitc Goat Anti-Human Igg Y ChainGelco Diagnostics, Inc.DEWClass II
K832261Goat Anti-Human Lamba AffinityGelco Diagnostics, Inc.DEHClass II
K832259Goat Anti-Human Igm H ChainGelco Diagnostics, Inc.DFTClass II
K832257Goat Anti-Human Iga a Chain SpecificGelco Diagnostics, Inc.CZNClass II
K832088Ames Tda Netilmicin Test & SerumMiles Laboratories, Inc.LCEClass II
K832020Hemocue Photometer Technical ManualAktiebolaget Leo DiagnosticsGKRClass II
K831967Critikon Cardiac Output ComputerCritikon Company, LLCDXGClass II
K831487Electroneural Stimulator 12Meridia 12 Corp.GZJClass II
K831224Augros HysterometerAxcan Scientific Corp.HHMClass I
K833227Sonicaid Model D206e Air Emboli-DetectSonicaid, Inc.LBAClass I
K833220Lowenstein-Jensen Medium BaseNeogen Culture MediaJSJClass I
K833219Staphylococcus Agar 10Neogen Culture MediaJSIClass I
K833218Yeast Beef Agar-Antibiotic Med.4Neogen Culture MediaLKAClass II
K833217Standard Method BrothNeogen Culture MediaJSGClass I
K833216Motility Test MediumNeogen Culture MediaJSHClass I
K833215Beef ExtractNeogen Culture MediaJSGClass I
K833214DextroseNeogen Culture Media
K833213Kligler Iron AgarNeogen Culture MediaJSHClass I
K833212Mac Conkey Agar without Crystal VioletNeogen Culture MediaJSIClass I
K833211Bile Salts MixtureNeogen Culture MediaJKSClass I
K833210LactoseNeogen Culture MediaJSKClass I
K833209Acidicase-Bb1Neogen Culture MediaJSGClass I
K833208Mr-Vp BrothNeogen Culture MediaJSHClass I
K833207Ak Agar 2Neogen Culture MediaLKAClass II
K833206Tech AgarNeogen Culture MediaJSHClass I
K833205Yersinia Selective AgarNeogen Culture MediaJSIClass I
K833204Deoxycholate Citrate AgarNeogen Culture MediaJSIClass I
K833203Deoxycholate Lactose AgarNeogen Culture MediaJSIClass I
K833202Moeller Decarboxylase BrothNeogen Culture MediaJSHClass I
K833201Simmons Citrate AgarNeogen Culture MediaJSHClass I
K833198Silicone Rubber Isolation Sleeve 351-01Intermedics, Inc.DXYClass III
K833195Umbrella WalkerConvaid Products LLCITJClass I
K833184Aplicare Three Alcohol SwabsticksAplicare, Inc.LKBUnclassified
K833182Aplicare Alcohol Prep PadAplicare, Inc.LKBUnclassified
K833181Hpr Home Patient RenatronRenal Systems, Inc.LIFClass II
K833164L-15-Leibovitz W/l-Glutamine-L4386Sigma Chemical Co.KITClass I
K833136Clostridium DifficileBD Becton Dickinson Vacutainer Systems PreanalyticJSJClass I
K833133Disposblade LaryngoscopeGeller & BozemanCCWClass I
K833131Hcc-Mycobacteria Stain KitDr. C.V. JacobLIBClass I
K833010Cin Agar Yersinia-Selective AgarBD Becton Dickinson Vacutainer Systems PreanalyticJSJClass I
K832985Tobramycin Analytical Test Pack-AcaE.I. Dupont de Nemours & Co., Inc.KLBClass II
K832982Aca Tobramycin CalibratorE.I. Dupont de Nemours & Co., Inc.DLJClass II