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 2661 of 3530
510(k) clearances, page 2661 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K891447Patient Examination Gloves (Latex)Lily Corp.LYYClass I
K891446Patient Examination Gloves (Latex)Felda Rubber Corp.LYYClass I
K891443Patient Examination Gloves (Latex)Sukas Sdn BhdLYYClass I
K891206Latex Examination GlovesCharug Fang Ent.LYYClass I
K891181Patient Examination Gloves (Latex)Behn Meyer & Co. (M) Sdn BhdLYYClass I
K891170Patient Examination Glove (Latex)Ching Pax Trading Co., Ltd.LYYClass I
K891152Grand Cooling MachineKCI USA, Inc.ILOClass II
K891067Patient Examination Glove, VinylSun Flower Gloves Co., Ltd.LYZClass I
K890881Teca 1A96, 1A97 and 1A98 ElectroencephalographsTeca, Inc.GWQClass II
K890861Ats Dobell & O'connor's IodineAlpha-Tec Systems, Inc.JTSClass I
K890857Patient Examination Gloves (Sterile & Non-Sterile)Health & Hospital Intl.LYYClass I
K890847Latex Examination GlovesPrime Merit Intl. Corp.LYYClass I
K890838Rehabot-YmImex Health, Inc.BXBClass I
K890767Ne-CheckStreck Laboratories, Inc.JPKClass II
K890627Unsterile Patient Examination GloveAladan Corp.LYYClass I
K890602Standing Dani WheelstandDavis Positioning Systems, Inc.IPLClass II
K890545Nu-Derm Hydrocolloid DressingJohnson & Johnson Patient Care, Inc.FROUnclassified
K890456Pti - Latex Examination GlovesPrecision Trading Intl., Inc.LYYClass I
K890436Technomed Pulsolith Laser SystemTeknomed, Inc.FFKClass II
K890147Rich-Mar Conductive Gel II W/aloe VeraRich-Mar Corp.IPFClass II
K890062Cadd-Pca Model 5800 Ambulatory Infusion PumpPharmacia Deltec, Inc.FRNClass II
K885316Disposable Intrauterine Pressure Kit Model 13972AHewlett-Packard Co.KXOClass II
K884990Ims-3 Picture Archiving SystemThe Biomedical Engineering CenterLMBClass I
K884849Biofeedback Device Access. Pi1,2,3,4,5/light BarMoeHCCClass II
K884345Model Esp-200 Mammographic SystemAcoma Medical Imaging, Inc.IZHClass II
K883829Turbo Air Compressor 8000Necon Medical, Inc.BTIClass II
K883391Polymer Adhesive BandageMarion Laboratories, Inc.NADClass I
K891348Campion Laser ForcepsSimpson/Basye, Inc.GENClass I
K891299Mid-Level Igg Kit Cat. No. 9315Helena Laboratories, Corp.DAQClass I
K891271Patient Examination Glove (Latex)Dr. Boo Co., Ltd.LYYClass I
K891257Defend Latex Examination GlovesCarl Parker Associates, Inc.LYYClass I
K891254Urological Stone BasketNorthgate Research, Inc.FFLClass II
K891253Urological Grasping ForcepsNorthgate Research, Inc.FGOClass II
K891252Urological Loop RetrieversNorthgate Research, Inc.FGOClass II
K891245Patient Examination Gloves (Latex)Terang Nusa (Malaysia) Sdn. Bhd.LYYClass I
K891232Patient Examination GlovesSupergrade Healthcare Products Sdn. Bhd.LYYClass I
K891220Sinton Latex Examination GloveSinton Latex Chemical Industries Co., Ltd.LYYClass I
K891218Iq/qca PhosphorusBD Becton Dickinson Vacutainer Systems PreanalyticCEOClass I
K891209Patient Examination Gloves (Latex)Chung Yuan Trading Co., Ltd.LYYClass I
K891207Latex Examination GlovesChung Yuan Rubber & Plastics Co.LYYClass I
K891205Latex Examination GlovesMing Hsien Rubber Industrial Co.LYYClass I
K891188Titan Gel Ife Trivalent AntiserumHelena Laboratories, Corp.CFQClass II
K891153Patient Examination Gloves (Latex)K.B. Latex Products Sdn. Bhd.LYYClass I
K891132Patient Examination GlovePhoenix Medical Technology, Inc.LYZClass I
K891099Anti-Skin Antibody Test(monkey/guin Pig Esoph Sec)Immco Diagnostics, Inc.DBLClass II
K891098Anti-Skin Antibody Test(monkey Esophagus Sections)Immco Diagnostics, Inc.DBLClass II
K891075Bard Neonatal ECG Monitoring ElectrodeC.R. Bard IncDRXClass II
K891048Ovum Forceps-Barret,javerts,willet,hansen,corey,mcZinnanti Surgical Instruments, Inc.KNAClass II
K891046Sopher and Bierer Ovum ForcepsZinnanti Surgical Instruments, Inc.KNAClass II
K891045Miya HookZinnanti Surgical Instruments, Inc.KNAClass II