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 2577 of 3530
510(k) clearances, page 2577 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K900107Ld-1Boehringer Mannheim Corp.DETClass I
K897114Emit Convenience Pack: Carbamazepine AssaySyva Co.KLTClass II
K896927Vision Theophylline IIAbbott MedicalKLSClass II
K896925T Uptake Enzyme Immunoassay Crimped Tube KitIn Vitro Diagnostics, Inc.KHQClass II
K896910Clinistat Albumin Reagent TestMiles Diagnostics Div.CIXClass II
K896569Electrotrace Disposable Ag/agcl EKG Monitor Elec.Jason Marketing Co.DRXClass II
K896535Medilog OptimaOxford Medilog, Inc.DSKClass II
K896396Mida System, Models 1000/1100Medical Graphics Corp.DYCClass II
K896346Gripper Port-a-Cath Needle with StopcockPharmacia Deltec, Inc.FPAClass II
K896293Virafree Corp. Ejectable Needle HolderVirafree Corp.FMIClass II
K896213Y-Type Tur/continuous Bladder Irrigation SetWestmark, Sterile Packing Systems, Inc. (Sps)KODClass II
K896211Cystoscopy/irrigation SetWestmark, Sterile Packing Systems, Inc. (Sps)KODClass II
K896210Gastric Sump TubeWestmark, Sterile Packing Systems, Inc. (Sps)KNTClass II
K896208Cysto Pump Drainage BagWestmark, Sterile Packing Systems, Inc. (Sps)KODClass II
K896184Kalos 05 Pulse GeneratorBiotronik Cardiac PacemakersDXYClass III
K896168Hemoglobin A2 Micro Column TestBio-RadJPDClass II
K896150Image 2000 System, Imaging, Ultra-SonicTeknar, Inc.IYOClass II
K896103Micro Fl 7400 Ambulatory Holter/bp MonitorAdvanced Medical Products, Inc.DSIClass II
K896102Micro Fd 7000 Ambulatory Blood Pressure MonitorAdvanced Medical Products, Inc.DXNClass II
K896034Procord Md3500 Vascular Diagnostic SystemD. E. Hokanson, Inc.DSBClass II
K895905Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-RadJJYClass I
K895662Defib K-PadsKatecho LLCLDDClass II
K895649Coated Tube High Sensitivity Tsh 200 Uiu/ml Stan.Ventrex Laboratories, Inc.JITClass II
K895648Coated Tube High Sensitivity Tsh 100 Uiu/ml Stan.Ventrex Laboratories, Inc.JITClass II
K894856CardiophoneEuro-American Marketing Group, Inc.DXHClass II
K894618Inamed Rhemo-D (Tm) DilatorInamed Development Co.FFPClass I
K894295Astro-Med Asc-951 Pressure ProcessorAstro-Med, Inc.DRQClass II
K893940Polystan Heater-Cooler UnitPolystan C/O Vitalcor, Inc.DWCClass II
K892528Five-Year Sterile Packaging Shelf LifeDaig Corp.DTBClass III
K897095Disposineedle Sharps Disposal UnitSpecialites SeptodontMMKClass II
K897047Latex Patient Examination GlovesP.T. Gotong Rojong DjajaLYYClass I
K897038Latex Patient Examination GlovesMulti Trading Corp. of America, Inc.LYYClass I
K896094Latex Examination GlovesMatang Mfg. Sdn. Bhd.LYYClass I
K896070Pfeiffer Metered Dosage SystemSyva Co.CCQClass I
K896016Latex Examination GlovesSudinar Sdn BhdLYYClass I
K895576Patient Examination GloveYong XU Co, Ltd.LYYClass I
K895490Yuetong Latex Examination GlovesThe New York Whitney GroupLYYClass I
K894767Corner SeatCanadian Posture and Seating Centre, Inc.INNClass I
K894495Surgitek(r) External Fill PortSurgitekLCJUnclassified
K893273Latex Examination GlovesTien Yee Screen Works Co., Ltd.LYYClass I
K893190Latex Examination GlovesChia Huang Cotton Mfg. Co.LYYClass I
K892947Vinyl Examination GlovesChung Kuo Industrial Co., Ltd.LYYClass I
K892899Sterile Latex Surgical GloveTomarc (M) Sdn BhdKGOClass I
K896594Ebv Vca Antibody (Igm)Hillcrest BiologicalsLJNClass I
K896529Basic Calcium Hydroxide LinerIvoclar North America, Inc.EJKClass II
K896301Model 340 Probe Mic SystemVirtual Corp.ETWClass II
K896216Hewlett Packard Anesthetic Gas Analyzer M1025aHewlett-Packard Co.CBSClass II
K896057Mini Primo Plus Asp Behind-the-Ear Hearing AidRexton, Inc.ESDClass I
K895443Model 210 Impedance SystemVirtual Corp.ETYClass II
K895303Ever-Sharp Biopsy ForcepsSouthwest Medical Mfg., Inc.HFBClass I