510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 of the 176,466 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
20262,669
176,466 records, page 2739 of 3530
510(k) clearances, page 2739 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K881572Xl Agar BaseNeogen Culture MediaJSIClass I
K881571Ym BrothNeogen Culture MediaJSJClass I
K881570Sabouraud Maltose AgarNeogen Culture MediaJSJClass I
K881569Stuarts Transport MediumNeogen Culture MediaJSMClass I
K881568Wilkens Chalgren BrothNeogen Culture MediaJSOClass II
K881567Wilkens Chalgren AgarNeogen Culture MediaJSOClass II
K881566Hemoglobin PowderNeogen Culture MediaJSKClass I
K881565Inhibitory Mold AgarNeogen Culture MediaJSJClass I
K881564Tryptose Blood Agar Base W/yeast ExtractNeogen Culture MediaJSGClass I
K881563Tryptose Phosphate BrothNeogen Culture MediaJSGClass I
K881562Tryptose Blood Agar BaseNeogen Culture MediaJSGClass I
K881561Tergitol 7 BrothNeogen Culture MediaJSJClass I
K881560Urea BrothNeogen Culture MediaJSHClass I
K881559Urea Agar BaseNeogen Culture MediaJSHClass I
K881558Tryptose AgarNeogen Culture MediaJSGClass I
K881557TryptoneNeogen Culture MediaJSGClass I
K881556Trichomonas BrothNeogen Culture MediaJSIClass I
K881555Tinsdale Agar BaseNeogen Culture MediaJSIClass I
K881554Skim Milk DehydratedNeogen Culture MediaJSGClass I
K881553Russell Double Sugar AgarNeogen Culture MediaJSHClass I
K881552Proteose No. 3 AgarNeogen Culture MediaJTYClass II
K881551Phenol Red Broth BaseNeogen Culture MediaJSHClass I
K881550Of Basal MediumNeogen Culture MediaJSGClass I
K881549Mycological Agar W/low PhNeogen Culture MediaJSJClass I
K881548Mph AgarNeogen Culture MediaJSGClass I
K881547Mitis Salivarius AgarNeogen Culture MediaJSJClass I
K881546Malt Extract AgarNeogen Culture MediaJSGClass I
K881545Malt ExtractNeogen Culture MediaJSGClass I
K881544Littman AgarNeogen Culture MediaJSJClass I
K881543Letheen AgarNeogen Culture MediaJSGClass I
K881542Heart Infusion AgarNeogen Culture MediaJSGClass I
K881541GelatinNeogen Culture MediaJSGClass I
K881540Flo AgarNeogen Culture MediaJSHClass I
K881539Amies Transport MediumNeogen Culture MediaJSMClass I
K881538Antibiotic Medium #10 Polymyxin Seed AgarNeogen Culture MediaJSAClass I
K881537Antibiotic Medium #19Neogen Culture MediaJSAClass I
K881536Antibiotic Medium #5 Streptomycin Assay AgarNeogen Culture MediaJSAClass I
K881535Antibiotic Medium #6Neogen Culture MediaJSAClass I
K881534Antibiotic Medium #9 Polymyxin Base AgarNeogen Culture MediaJSAClass I
K881533Blood Agar Base No. 2Neogen Culture MediaJSGClass I
K881532Blood Agar Base W/low PhNeogen Culture MediaJSGClass I
K881531Blood Agar Base, ImprovedNeogen Culture MediaJSGClass I
K881530Brilliant Green Agar W/sulfadiazineNeogen Culture MediaJSJClass I
K881529Cary and Blair Transport MediumNeogen Culture MediaJSMClass I
K881528Casein Peptone, Low VitaminNeogen Culture MediaJSGClass I
K881527Casman Medium BaseNeogen Culture MediaJTYClass II
K881526Chapman Stone MediumNeogen Culture MediaJSJClass I
K881525Cooked Meat MediumNeogen Culture MediaJSGClass I
K881524Dermatophyte Test MediumNeogen Culture MediaJSJClass I
K881523Dextrose Tryptone BrothNeogen Culture MediaJSGClass I