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 2592 of 3530
510(k) clearances, page 2592 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K896052Fibrinogen Assay KitMedical Diagnostic Technologies, Inc.KQJClass II
K896044Cross Cancellous Bone ScrewBuckman Co., Inc.HWCClass II
K895081Promontory Stimulating ElectrodeCadwell Laboratories, Inc.GXYClass II
K891004Rapidec StaphDms Products, Inc.LQLClass I
K896327Surgeon's GlovesProductes del Latex, S.A.KGOClass I
K896272Quantex Crp Plus (Latex, Buffer, Standard, ControlBiokit USA, Inc.DCNClass II
K896271Quantex RF Plus (Latex, Buffer Standard, Control)Biokit USA, Inc.DHRClass II
K896256Reflux BedCozcon, Inc.INWClass I
K896085Surgi-BrushSparta Surgical Corp.GECClass I
K896021Cedia Digitoxin AssayMicrogenics CorporationLFMClass II
K895984Wako(tm) Autokit Gamma-GtFUJIFILM Healthcare Americas CorporationJPZClass I
K895911One Touch II MeterLifescan, Inc.CGAClass II
K895804Shannon Latex Medical GlovesCashmor Mfg., Ltd.LYYClass I
K895766Asnis II Guided Bone ScrewHowmedica Corp.HWCClass II
K895759Hollow Fiber Dialyzer Series Focus 160/160HNational Medical Care, Medical Products Div., Inc.KDIClass II
K895737The Doctor's Choice ElectrodeThe Skin Care CentreGEIClass II
K895686Daily Activity Assist Device (Mobile Standing Aid)Stand-N-Go Corp.IPLClass II
K895600Human (Igg) Subclass (Eia) KitThe Binding SiteDASClass I
K895552Latex Examination GlovesJung Hua Co.LYYClass I
K895381Hdl SinglesTrace America, Inc.LBRClass I
K895281Transducer ProtectorFiltertek, Inc.FIBClass II
K895279Lasermatic Combolaser Model 5050Lasermatic, Inc.GEXClass II
K895220The on-Gard RecapperOn-Gard Systems, Inc.FMFClass II
K895186Fiagen T3 Uptake Catalogue #101-402Cyberfluor, Inc.KHQClass II
K895175Nf-1 MindpeaceNeurofitnessQJQClass II
K895043Coma Cocaine Metabolite Assay (Eia)Serex, Inc.DIOClass II
K894990Davol Arthroscopy CannulaDavol, Inc.HRXClass II
K894968UltracompactEutectic Electronics, Inc.EXYClass II
K894715Creatine Kinase for Manual/automated ApplicationsCatachem, Inc.CGSClass II
K894106Drake Willock Reverse Osmosis Water Treatment SystCd Medical, Inc.FIPClass II
K893661Quantai Ug Reagent StripQuantai Biotronics, Inc.CGAClass II
K893350Latex Examination GlovesPan Africa Exports, Ltd.LYYClass I
K892856Newmark(tm) Coronary Artery Bypass Graft MarkersAcacia Laboratories, Inc.KRIClass I
K892443Blood Recovery/autotransfusion Reservoir Atr-2900Gish Biomedical, Inc.CACClass II
K895354Intrasite Cavity Wound DressingSmith & Nephew United, Inc.KOZClass I
K895171Blood Gas Safety SyringeKronner MedicalCBTClass I
K895130Heimlich Micro TrachBallard Medical ProductsBTOClass II
K894967Latex Patient Examination GlovesYan Ling Rubber Products Co.LYYClass I
K894387Westco Madayag Pab NeedleWestern Medical, Ltd.HAWClass II
K894194Latex Exam Gloves (Mfg: China Nat Chem Const Corp)Invent Ent. (U.S.A.) Corp.LYYClass I
K893804Latex Examination GlovesS-P Pantec Co., Ltd.LYYClass I
K893075Patient Examination GlovesQuality Latex Corp. Sdn BhdLYYClass I
K892571Patient Examination Gloves (Latex)Sinopac Marketing, Inc.LYYClass I
K892076Patient Examination Gloves (Latex)M/S Shanghai Knitwear Import & Export Corp.LYYClass I
K891182Patient Examination GlovesRaystar Engineering & Construction Sdn BhdLYYClass I
K896059Modified Qm300 Albumin Antibody PackKallestad Diag, A Div. of Erbamont, Inc.DCFClass II
K895997Rheumelisa Assay for Rnp AutoantibodiesLipogen, Inc.LKOClass II
K895996Rheumelisa Assay for Sm AutoantibodiesLipogen, Inc.LKPClass II
K895730X-Ray Equipment (Various Types)Continental X-Ray Corp.JAAClass II
K895725Biopsy Needle Guide for Adms Ultrasound ProbesInterson Corp.FCGClass II