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 2643 of 3530
510(k) clearances, page 2643 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K891189Wedge Pressure DressingDurden Enterprises, Inc.FROUnclassified
K891133Variously Sized Sterile Cotton Wound DressingsElwyn, Inc.FROUnclassified
K891077Mediverse Parenteral Nutrition BagMediflex Intl.KPEClass II
K891006Quick-Tip (Dental Operatory Unit)Bernard S EsrockEIAClass I
K890095PVC Empty Solution Container W/3 Lead Transfer SetKells Medical, Inc.KPEClass II
K890094Eva Empty Solution Container W/3 Lead Transfer SetKells Medical, Inc.KPEClass II
K885345HealthshieldJonas, Inc.KPNClass II
K884882Orient, Latex Surgical Gloves, SterileRosa Intl.KGOClass I
K884652OctyldentCrx Medical, Inc.EMAClass II
K883462If-II (Tm), Model 9800Medical Devices Inc.LIHClass II
K882558Areola/nipple DressingCooper Surgical/AestheteNADClass I
K893013Luxar Endoguide CO2 Laser WaveguideLuxar Medical Laser InstrumentsGEXClass II
K892398Bipolar Hip SystemOrthomet, Inc.KXAClass II
K892061Grand Guard Surgical GlovesGalaxy Intl., Inc.KGOClass I
K892006Healthdyne's Apnea/heart Monitor, Model 900SHealthdyne, Inc.DRTClass II
K891601Power Operated and Controlled Vitreous ScissorsMira, Inc.HQEClass II
K891387Williams Belt & BootArthro-Medic, Inc.JEBClass I
K891290Sholkoff Balloon Hysterosalpingography CatheterCook Ob/GynHESClass II
K891178Tecnol Secure-All Tube HolderTecnol New Jersey Wound Care, Inc.EYZClass I
K891130Light-Touch Laparoscopic Model 905200 FiberopticLifestream Int'L, Inc.GEXClass II
K890977Mcintyre Surgical GoniolensOcular Instruments, Inc.HKSClass I
K890603Beam Tech Wound Dressing*Beam Tech, Ltd.NADClass I
K890515Peripheral Atherectomy SystemIntensive Technology, Inc.DWXClass II
K890465Closed System Urinary Drainage BagCypress Medical Products LLCEYZClass I
K890396External Feeding Set for Pump UseMulti-Med, Inc.FPDClass II
K890151Enteral Bag/setAshley Health Care, Inc.KNTClass II
K890113The Cdi(r) System 400Cardiovascular Devices, Inc.DJYClass I
K885191Mrl Blood Pressure MonitorMedical Research Laboratories, Inc.DXNClass II
K892943Multi Pulse Power Unit GeneratorGE HealthcareIZOClass I
K892938Amnio-Grow TmInovar Biologicals, Inc.KITClass I
K892909Argelite 80Sf+ Dental AlloyArgen Precious Metals, Inc.EJTClass II
K892900Aca Vancomycin (Vanc) MethodE.I. Dupont de Nemours & Co., Inc.LEHClass II
K892853T4 Clasp-Bead Eia KitBiotecx Laboratories, Inc.KLIClass II
K892819Autotransfusion DeviceImpra, Inc.CACClass II
K892814Argedent 45Argen Precious Metals, Inc.EJTClass II
K892747Non-Sterile Patient Examination Gloves (Latex)Asia Way Trading, Inc.LYYClass I
K892656Dri-Dye Check Strips (Tm)-405Awareness Technology, Inc.JJXClass I
K892103Patient Examination Gloves (Latex)Jenq Chuam Industrial Co., Ltd.LYYClass I
K892093Patient Examination Gloves (Latex)Wah Chiang Ent. Sdn BhdLYYClass I
K891968Esp Radiation Reduction Examination GlovesBoston Scientific CorporationLZCClass I
K891640Patient Examination Gloves (Latex)(powdered)Perusahaan Getah Asas Sdn. Bhd.LYYClass I
K891638Patient Examination Gloves (Latex)Tak Ent., Inc.LYYClass I
K891578Avl Model 987 Electrolyte AnalyzerAvl Scientific Corp.CHLClass II
K891480Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerYellow Springs Instrument Co., Inc.CGAClass II
K891468Ast (Got) Ifcc 2-Vial Reagent W/pyridoxyl PhosphatTrace Scientific, Ltd.CITClass II
K891462Roche(r) Cardioscreen-CkRoche Diagnostic Systems, Inc.CGSClass II
K891177Patient Examination Gloves (Latex)Garrett-Hewitt Intl., Inc.LYYClass I
K891015Coag-1 Aptt Test CardCardiovascular Diagnostic ServicesGFOClass II
K890958Oxitron Oxygen AnalyzerOxitron Medical ProductsCCLClass II
K890939Dupont Distal Humeral NailHowmedica Corp.HRSClass II