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 2616 of 3530
510(k) clearances, page 2616 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K894293Mardx Lyme Disease Eia (Igm) Test SystemMardx Diagnostics, Inc.LSRClass II
K894272Denley Welldill 3Denley Instruments, Inc.JQWClass I
K894270Denley Anthos 2001 ReaderDenley Instruments, Inc.JJQClass I
K894224Mardx Lyme Disease Eia (Igg) Test SystemMardx Diagnostics, Inc.LSRClass II
K894141Liquid Chromatography ColumnsSupelco, Inc.DPMClass I
K894120Madegom Ltda. Dental DamMadegomEIEClass I
K894069Abbott Commander Flexible Pipetting CenterAbbott MedicalJQWClass I
K894013Non-Sterile Latex Examination GlovesNova Rubber Glove Industries Sdn. Bhd.LYYClass I
K893913Technicon Ra Systems Tobramycin Test MethodTechnicon Instruments Corp.KLBClass II
K893912Technicon Ra Systems Gentamicin Test MethodTechnicon Instruments Corp.LCDClass II
K893910Emit Convenience Pack: Digoxin AssaySyva Co.KXTClass II
K893886Mitek Sterilization TrayMitek Surgical Products, Inc.FLEClass II
K893873Single and Dual Band Dipstick Hcg TestAmpcor, Inc.DHAClass II
K893803Fever Line and Fever Line PlusLiquid Crystal Sciences, Inc.KPDClass II
K893777Albumin Test (Alb) Item Number: 65401Em Diagnostic Systems, Inc.CIXClass II
K893755RubagenBiokit USA, Inc.LQNClass II
K893714Keystone Oxygen TentKeystone Veterinary Supplies, Inc.BYLClass I
K893713Nova Oxygen TentNova Health Systems, Inc.BYLClass I
K893692Emds Aspartate Aminotransferase Item Number 65405Diagnostic SystemsCITClass II
K893667Suction TipThomson & Shelton Instrumentation Co, Inc.JOLClass II
K893665Aerosol Inhalation MonitorVitalograph, Inc.BWFClass II
K893649Meconium AspiratorGish Biomedical, Inc.GCXClass II
K893532Resubmitted Radioaerosol Cont. System Mp-963Medipart Jerry AlexanderCBNClass II
K893520Dr. Boo Latex Examination GlovesDynatech Medical ProductsLYYClass I
K893512Depuy Cannulated Bone ScrewDepuy, Inc.HWCClass II
K893431Auditory Trainer Pe150r Fm ReceiverPhonic Ear, Inc.EPFClass II
K893372Latex Examination GlovesOriental Medical Supplies, Inc.LYYClass I
K893368Vinyl Examination GlovesChuan Ming Plastic Industrial Co., Ltd.LYZClass I
K893152S,m,l Latex Examination GlovesKc-Courser Ent. Co., Ltd.LYYClass I
K893055Latex Examination GlovesPro Brand Intl., Inc.LYYClass I
K893054Latex Examination GlovesAlfa Technologies, Inc.LYYClass I
K892954Patient Examination Gloves (Latex)Evermore Latex Products Co., Ltd.LYYClass I
K892948Handcare Patient Examination GlovesSouth Pacific Chemical Industries Sdn BhdLYYClass I
K892787Patient Examination Gloves (Latex)New World Projects, Inc.LYYClass I
K892632Patient Examination Gloves (Latex)Mlb Holdings Sdn. Bhd.LYYClass I
K892626Patient Examination Gloves (Latex)Aik Poh Rubber Industries Sdn. Bhd.LYYClass I
K892517Tulux-FilterEspe GmbH (US)EBZClass II
K892246Champ-Paq Vinyl Patient Examination GlovesB und J Instrument, Inc.LYZClass I
K892245Champ-Paq Latex Patient Examination GlovesB und J Instrument, Inc.LYYClass I
K892244Champ-Paq Vinyl Patient Examination GlovesChamp-Paq Instrument Corp.LYZClass I
K892243Champ-Paq Latex Patient Exam GlovesChamp-Paq Instrument Corp.LYYClass I
K892215Uni-Shunt(tm) with Elliptical Reservoir KitCerenovus, Inc.JXGClass II
K892031Patient Examination Gloves (Latex)Speedtech Sdn BhdLYYClass I
K891950Patient Examination Gloves (Latex)Rextex Rubber Products (M) Sdn. Bhd.LYYClass I
K891926Kiss of LifeAnthony Don Michael, M.D.CAEClass I
K891772Spectinomycin 100 Mcg Sensi-DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K891693Automated Therapy SystemHarding & Harris, Inc.HCCClass II
K891316Anesthesia/respiratory Disposable MaskConcord/PortexBSJClass I
K884157Modified Touch-Me-Not MaskWalt'S ProductsBSJClass I
K883505Biometer AudiometerMicro Audiometrics CorporationEWOClass II