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 2826 of 3529
510(k) clearances, page 2826 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K870532Galaxy Powered WheelchairGlobal Research, Inc.ITIClass II
K870416Lp Extension SetsNorth Coast Medi-TekFPKClass II
K870251Chondroitin Sulfate Corneal Storage MediumBioclinical Laboratory Services, Inc.LYXUnclassified
K870250Modified Mccarey-Kaufman Corneal Storage MediumBioclinical Laboratory Services, Inc.LYXUnclassified
K870249Mccarey-Kaufman Corneal Storage MediumBioclinical Laboratory Services, Inc.LYXUnclassified
K870169Capillary Flow DialyzersTravenol Laboratories, S.A.FJIClass II
K870149Model Cbc-1 Coa-Comp Anti-Sticking Biopolar Coag.Radionics, Inc.GEIClass II
K863846Contac CaseS. M. C. Medi-Tech Corp.LPNClass II
K871238AnabagScott Laboratories, Inc.KZJClass I
K871191(Dmf/f-12) Hybri-Max(tm) W/l-GlutamineSigma Chemical Co.KITClass I
K871165Lumifor(tm) CompositeColumbus Dental Mfg. Co.EBFClass II
K871117Tb Quick Stain(tm) KitBD Becton Dickinson Vacutainer Systems PreanalyticICJClass I
K871098Tryptic Soy AgarbioMerieux, Inc.JSGClass I
K871097Chocolate Mueller Hinton AgarbioMerieux, Inc.JTZClass II
K871096Cystine Tryptic Agar W/o CarbohydratesbioMerieux, Inc.JSEClass I
K871095Cled AgarbioMerieux, Inc.JSHClass I
K871094Brilliant Green AgarbioMerieux, Inc.JSIClass I
K871093Chocolate Agar W/bacitracin (Haem. Isol. Agar)bioMerieux, Inc.JSJClass I
K871092Horse Blood Agar, EnrichedbioMerieux, Inc.KZIClass I
K871091Bacteroides Bile Esculin AgarbioMerieux, Inc.JSJClass I
K871090Anaerobic Pea Blood AgarbioMerieux, Inc.JSJClass I
K871089Anaerobic Blood Agar (Cdc Formulation)bioMerieux, Inc.JSGClass I
K871088Anaerobic Lkv Blood AgarbioMerieux, Inc.JSIClass I
K871057Mc-Series Surgical CamerasM.P. Video, Inc.FWBClass I
K870942Mvs Fiberoptic LightpipeAdvanced Surgical Products, Inc.FSTClass II
K870921Dental Needle (Cartridge Type)Churchill Corp.DZMClass I
K870769Austin Nonfermenter KitAustin Biological LaboratoriesJSWClass I
K870717Spottest MicrodaseDifco Laboratories, Inc.JTOClass I
K870716Spottest 10% Sodium DesoxycholateDifco Laboratories, Inc.JTOClass I
K870589Elevator, Root, Single-EndedMilitary Engineering, Inc.EMJClass I
K870477Device Connectors #000299-000 3/8 X 3/8 X 3/8 YClinical Connections, Inc.
K870388Hoffmann Leg Lengthening Plate SystemHowmedica Corp.HRSClass II
K870317Ivac (R) Site-Saver (Tm) Volumetric Controller 280YLDRClass II
K870262Fenlin II Shoulder ProsthesisZimmer GmbHKWSClass II
K870173Lavabed System & Chamber, Lavapak Temp. ControlMauna Loa Medical, Inc.BTTClass II
K864086Vapor-Seal(tm) Percutaneous CathetersPharmacia, Inc.LJSClass II
K863818Pm-100 Thermograph Mark 1026Clearwater Computer Center, Inc.LHQClass I
K871169Lubricating JellyH & P Industries, Inc.KMJClass I
K871167SensitesterDexin Pty., Ltd.GWYClass I
K870977Pharmaseal T Type Thermocouple 100% Cath./probeAmerican Pharmaseal Div. AhscKODClass II
K870951Digoxin Fpia Reagent SetSigma Diagnostics, Inc.KXTClass II
K870915Simpulse Arthroscopy Irrigation SystemC.R. Bard IncHRXClass II
K870836Atac 1500 Chemistry AnalyzerTurpen Laboratory Systems, Inc.JJEClass I
K870833Ciba Corning/shimadzu Model 580 Clini. Chem. AnalyCiba Corning Diagnostics Corp.JJEClass I
K870796Macbick-Xl Basic Air Contast Barium Enema Deliv SyPlasco, Inc.FCEClass I
K870790Reflective Mirror/co2 Laser Surg Cat. #902002-000Lifestream Int'L, Inc.FTXClass I
K870785Soft Tissue Biopsy NeedleBD Becton Dickinson Vacutainer Systems PreanalyticKNWClass II
K870724Fresenius Hemoflow F60 and F80Seratronics, Inc.KDIClass II
K870672Aca Human Chorionic Gonadotropin (Hcg) MethodE.I. Dupont de Nemours & Co., Inc.JHIClass II
K870586Tdcontrol Liquid Multi-Analyte Therapeutic DrugMedical Analysis Systems, Inc.DIFClass I