510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3292 of 3528
510(k) clearances, page 3292 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811348Cardiopulmonary Bypass Accessory Equip.Bentley Laboratories, Inc.KRIClass I
K811340Thioglycollate Medium W/out IndicatorNeogen Culture MediaJSGClass I
K811339Todd Hewitt BrothNeogen Culture MediaJSJClass I
K811338Violet Red Bile AgarNeogen Culture MediaJSIClass I
K811337Tergitol 7 AgarNeogen Culture MediaJSJClass I
K811336M-Green Yeast & Mold BrothNeogen Culture MediaJSJClass I
K811335Thioglycollate Gelatin MediumNeogen Culture MediaJSHClass I
K811334MycoselNeogen Culture MediaJSIClass I
K811333Ec MediumNeogen Culture MediaJSJClass I
K811332Brain Heart Cc AgarNeogen Culture MediaJSIClass I
K811331Sf BrothNeogen Culture MediaJSIClass I
K811330Sim MediumNeogen Culture MediaJSHClass I
K811329Schaedler BrothNeogen Culture MediaJSJClass I
K811317Howmedica Femoral Pressuring SealHowmedica Corp.KIHClass I
K811263Tox Tm AnalyzerAbbott MedicalJQZClass I
K811213T3 (Ria) KitImmuno Assay Corp.CDPClass II
K811062Campbridge ComputraceCambridge Instruments, Inc.DXGClass II
K810976Alpha-Thal Screen Tm ControlIsolab, Inc.LGLClass II
K810853Ck-Total/ck-B (Nac) Biolumin. Assay KitThe Upjohn Co.CGSClass II
K810489Multilith Pulse Generator #1140Ela Medical, Inc.DXYClass III
K810239Vented Primary Piggyback Venoset DualAbbott MedicalFPAClass II
K810142Ela Medical Unilith Pulse GeneratorEla Medical, Inc.DXYClass III
K802913Tan Dem* - Ige KitHybritech, Inc.DGCClass II
K811343Humeral Fracture Cast BraceDeseret Medical, Inc.IQIClass I
K811328Schaedler AgarNeogen Culture MediaJSJClass I
K811327Salmonella Shigella AgarNeogen Culture MediaJSIClass I
K811326Sabouraud Liquid, Broth ModifiedNeogen Culture MediaJSDClass I
K811325Sabouraud Dextrose AgarNeogen Culture MediaJSJClass I
K811324Phenylethanol AgarNeogen Culture MediaJSIClass I
K811323Nutrient BrothNeogen Culture MediaJSCClass I
K811322Potato Dextrose AgarNeogen Culture MediaJSJClass I
K811321Standard Methods AgarNeogen Culture MediaJSGClass I
K811315Coat-a-Count T4 Ria KitSiemens Healthcare Diagnostics Inc.CDXClass II
K811304Liquid Chromatography ColumnsSupelco, Inc.DPMClass I
K811301TubmateAmerican Stair-Glide Corp.ILSClass I
K811298Executive CollarOrthomedicsIQKClass I
K811297Cervical SupportOrthomedicsIQFClass I
K811289Nova 5Nova Biomedical CorporationJGSClass II
K811274Prostatic Acid Phosphatase Radioimm. KitBD Becton Dickinson Vacutainer Systems PreanalyticJFHClass II
K811273Cyclic Amp Radioimmunoassay Kit [125I]BD Becton Dickinson Vacutainer Systems PreanalyticCHOClass II
K811262Epstein-Barr Virus Capsid Antigen AntiZeus Scientific LLCJRYClass I
K811260Baralyme CO2 AbsorbentAllied Medical LLCCBLClass I
K811257Corning 965 Carbon Dioxide AnalyzerCorning Medical & ScientificCHSClass II
K811241Bodai Suction -Safe 4Sontek Industries, Inc.BSYClass I
K811221Intermedics Cyberlith Bipolar CardiacIntermedics, Inc.DXYClass III
K811202Ultrachem Gluc-Dh, Item No. 65048HarlecoLFRClass II
K811194Hitachi 705 Automatic Blood ChemistryBoehringer Mannheim Corp.JJEClass I
K811191Davis & Geck Needle/sharps CounterDavis & Geck, Inc.KDCClass I
K811187Medtronic A2 Clinical Imaging SystemMedtronic, Inc.IYXClass I
K811175Recoh Root Canal IrrigatorKoei International, Inc.EFSClass I