510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3055 of 3529
510(k) clearances, page 3055 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K842765Silimed Breast FormSil-Med Corp.GBIClass I
K842762Omni-Tract Surgical Retractor SysMinnesota Scientific, Inc.GADClass I
K842750Osmotic Pressure Auto & Stat Om-6010Kyoto Diagnostics, Inc.JJMClass I
K842746Hycel Rotor-Mixer And/or MultiR & D Systems, Inc.KSQClass I
K842740Delafield Hematoxylin StainE K Ind., Inc.HYJClass I
K842738Pap Stain Ea-50E K Ind., Inc.HZJClass I
K842736Pap Stain, Og-6E K Ind., Inc.HZJClass I
K842734Safranin StainE K Ind., Inc.HZSClass I
K842657Access. to Interavacular Admin. SetTanner Corp.FPAClass II
K842606Coat-a-Count Dhea Ria KitSiemens Healthcare Diagnostics Inc.JKCClass I
K842592Ames Tda Phenobarbital TestMiles Laboratories, Inc.LETClass II
K842552Coat-a-Count Dhea-So4 Ria KitSiemens Healthcare Diagnostics Inc.JKCClass I
K842536Cdx80Cdx Corp.BZGClass II
K842519Blood Gas Flush Sol. & Flush Agent 1302Rna Medical Corp.CHLClass II
K842516Sandare Acid Phosphatase ProcedureSandare Chemical Co., Inc.CJRClass II
K842495Matrix Video Imager 1020 Compact CamerMatrix InstrumentsIZIClass II
K842494Matris Instru. Video Imager 1010-Matrix InstrumentsIZIClass II
K842490Skin Scrub Tray Sterile Skin Scrub KitBiological & Environmental Control LaboratoriesFRGClass II
K842444Fsh RiaSyncor Intl. Corp.CGJClass I
K842421Argyle Enterite Enteral Feeding PumpSherwood Medical Co.FRNClass II
K842403Luster, Dental Polishing PasteScientific Pharmaceuticals, Inc.EJRClass I
K842385Aca Conjugated Bilirubin AnalyticalE.I. Dupont de Nemours & Co., Inc.CIGClass II
K842367Howmedica Kinematic II Tibial WedgeHowmedica Corp.HRYClass II
K842348Spx GeneratorGeneral Electric Co.IZOClass I
K842345Maxifill Transfer SetLyphomed, Inc.LHIClass II
K842337Shiley Venous ReservoirShiley, Inc.DTNClass II
K842323Amer. Edwards Lab Flexiscope ObturatorAmerican Edwards LaboratoriesHRXClass II
K842255Aimed Scalp Vein Set VariousTech-Cons Ltd., Intl.
K842230Aimed Dispos. Injection NeedleTech-Cons Ltd., Intl.GAAClass I
K842160Cholesterol Asssay KitDiagnostic Chemicals, Ltd. (USA)CHHClass I
K842099Acth Standard MatrixDiagnostic Systems Laboratories, Inc.JITClass II
K842088Flu Met 2Venusa Ltd.FPAClass II
K842014Hospital's-SpecMerex Co.HIBClass II
K841847Lithium ReagentReagent Laboratory, Inc.JJOClass I
K841817Technicare 248 Sl & 260SlTechnicare Corp.IYOClass II
K841275Fine Needle Aspiration DeviceGyneco, Inc.DRMClass II
K841040Fox Post Nasal Balloon CatheterInmed Corp.EMXClass I
K840949Clear Plastic-HypoallergenicGainor MedicalKGXClass I
K840947Cloth-HypoallergenicGainor MedicalKGXClass I
K840946Microporous HypoallergenicGainor MedicalKGWClass II
K840447Microporous Med. Adhesive TapeLectec Corp.KGXClass I
K842827Streptex Direct a Zl14Wellcome DiagnosticsGTZClass I
K842655Epsilon Digoxin Test KitBeckman Instruments, Inc.KXTClass II
K842571Immpulse Digoxin Assay ReagentsAktis Corp.KXTClass II
K842549Aca Acetaminophen CalibratorE.I. Dupont de Nemours & Co., Inc.
K842548Aca Acetaminophen Analytical Test PackE.I. Dupont de Nemours & Co., Inc.LDPClass II
K842500Data Mgmt. SystemGilfordJJEClass I
K842455Amer. Bio-Science Lab Cortisol ReagentAmerican Bio-Science LaboratoriesCGRClass II
K842450Hichem Ion 2/4 Urine Range CalibratorHi Chem, Inc.JISClass II
K842449Hichem Ion 2/4 Serum Range CalibratorHi Chem, Inc.JISClass II