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 3091 of 3528
510(k) clearances, page 3091 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K833669Image DeflectorMichael OnufrykHPAClass I
K841383Cspi Rotary Surgical AspiratorCustom Surgical Products, Inc.
K841253Compression Stockings W/waist Suspens-Baurs Krey Assoc., Inc.
K841144Chocolate Agar W/cofactorAnaerobe SystemsJSGClass I
K841143Columbia Agar W/5% Sheep BloodAnaerobe SystemsJSGClass I
K841141Macconkey AgarAnaerobe SystemsJSIClass I
K841140Phenylethyl Alcohol Blood AgarAnaerobe SystemsJSJClass I
K841139Columbia Agar W/colistin, NaladixicAnaerobe SystemsJSJClass I
K841137Mueller Hinton Agar W/wo BloodAnaerobe SystemsJTZClass II
K841136Sabouraud Dextrose Agar W/chlorampheAnaerobe SystemsJSJClass I
K841135Mycosel Agar W/chloramphenicol &Anaerobe SystemsJSJClass I
K841134Mannitol Salt AgarAnaerobe SystemsJSIClass I
K840344Pdi Prepmaster Wet Pack Minor ProcedureNice-Pak Products, LLCFRGClass II
K841242Cspi Premium Surgical AspiratorCustom Surgical Products, Inc.
K841133Thayer Martin MediumAnaerobe SystemsJSJClass I
K841132Eile-Esculin Azide AgarAnaerobe SystemsJSIClass I
K841131Xylose Lysine Desoxycholate AgarAnaerobe SystemsJSIClass I
K841130Trypticase Soy Agar W/5% Sheep BloodAnaerobe SystemsJSGClass I
K841129Hektoen Enteric AgarAnaerobe SystemsJSIClass I
K841100Hp-20, 30, 40, 50 & 60Associated Mills, Inc.IRTClass II
K841093Nasopharyngeal AirwaysInmed Corp.BTQClass I
K841057Hemoglobin Reagent SetMedical Specialties Inc.GKRClass II
K840991Preserv Buffered Glycerol SalinePreventive Diagnostics Corp.JTWClass I
K840990Preserv Cary Blair Transport PackPreventive Diagnostics Corp.JTWClass I
K840981Niacin Reagent StripRemel Co.MJDClass II
K840968Preserv Transport & Culture PackPreventive Diagnostics Corp.JTWClass I
K840967Ohio Heat Reflecting PatchOhio Medical ProductsFMIClass II
K840924Syringe, Piston, Arterial Blood SamplMedcare Disp Products, Inc.FMFClass II
K840896Differentiation Disks AlaDifco Laboratories, Inc.JTOClass I
K840894Photo-Therapy Eye ProtectorA & a Medical Supplies Inc.FOKClass I
K840890Buffered Cye Agar Deep W/supplementsRemel Co.JSJClass I
K840889Clostridium Difficile Agar Deep &Remel Co.JSIClass I
K840884Strep-a-Chek TubeE-Y Laboratories, Inc.JTOClass I
K840858Ohio 3300 Infant Warmer SystemOhio Medical ProductsFMTClass II
K840857Ohio 3000 Infant Warmer SystemOhio Medical ProductsFMTClass II
K840823Treonic C30Vickers America Medical Corp.LDRClass II
K840819MicrodaseRemel Co.JTOClass I
K840804Differentiation Disks SpsDifco Laboratories, Inc.JTOClass I
K840800Polyp-Saver SleveJayco PharmaceuticalsOCZClass II
K840699Crp Slide Test KitDifco Laboratories, Inc.DCNClass II
K840644Flo-Gard 4000 Volumetric InfusionTravenol Laboratories, S.A.LDRClass II
K840617Masterfoot Cast HeelSeton Products, Inc.LGFClass I
K840597Quinidine CalibratorE.I. Dupont de Nemours & Co., Inc.DLJClass II
K840592Electrode Placement Lumbar ShortsBio-Stimu Trend Corp.GXYClass II
K840591Electrode Placement SleeveBio-Stimu Trend Corp.GXYClass II
K840551MobilizerLossing Orthopedic, Inc.IONClass I
K840543Blood Concentrator 140Gambro, Inc.KDIClass II
K840538Phadexact Serum, Allergen Specific IgePharmacia, Inc.DGCClass II
K840514Neisseria Meningitidis ControlScientific Device Laboratory, Inc.LSCClass I
K840513Streptococcus Gr. B ControlScientific Device Laboratory, Inc.GTYClass I