510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 2308 of 3531
510(k) clearances, page 2308 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K922487Bio-Interfaces 1840 Porous Ha Particles-Bii-PoreBio-Interfaces, Inc.LYCClass II
K915594Stability Hip Femoral ComponentDepuy, Inc.JDIClass II
K930875Ckmb Control - Level 1,2,3Cala DiagnosticsJJTClass I
K930873Ckmb Isoenzyme Control-Level 1,2.3Cala DiagnosticsJJTClass I
K930220Cassette, Radiographic FilmX-Ray Accessories Mfg. Co.IXAClass II
K924908Cell Collecting BrushAnderson Winn Paper Co.HHTClass II
K923992Power Pack 350/Battery Pack 351Siemens Medical Solutions USA, Inc.CBKClass II
K923738High Dose Rate Remote Afterloading CatheterCook Inc.JAQClass II
K931000Siemens Model 584-P-Ai-DSiemens Hearing Instruments, Inc.ESDClass I
K930999Siemens Model 584-P-AiSiemens Hearing Instruments, Inc.ESDClass I
K930998Siemens Model 584-P-GcSiemens Hearing Instruments, Inc.ESDClass I
K930359Cardio Rep-Cat. No. 1400 & Ck Isoforms Kit 3305Helena Laboratories, Corp.JHTClass II
K930327Il Test(tm) Protein SInstrumentation Laboratory Co.GGPClass II
K925358Dermatouch Plus Hypoallergenic Examination GlovesColonial Surgical Supply, Inc.LYYClass I
K923473Multipurpose Resin CementDentsply Intl.EMAClass II
K9301349055 Irca Option for System Athena 9050 NtS & W Medico TeknikDPSClass II
K924652Benson Cca100Benson Medical Instruments Co.EWGClass II
K923590318A Respiratory Support SystemMedtronic, Inc.BZDClass II
K914164Vitalmax 840 SeriesPace Tech Medical Monitors, Inc.BXNClass II
K931038Connectors and Airway ExtensionsMed-Plastics Intl., Inc.BZAClass I
K931036Connectors and Airway ExtensionsLife Shield Healthcare Products, Inc.BZAClass I
K930777Thyroglobulin Autoantibody Immunoassay KitNichols InstituteJNLClass II
K930455Chameleon Light/chemical Cure Glass IonomerVoco GmbHEMAClass II
K930070Hemocard Hemoglobin EIsolab, Inc.CKAClass I
K926492Argion Dental CementVoco GmbHEMAClass II
K926457Scimed(r) 0.038 Controlwire(tm) Peripher Guide WirScimed Life Systems, Inc.DQXClass II
K926044Mpm Wet Dressing (Saline)MPM MedicalKMFClass I
K925924Neal Wrist ConesNeal & Assoc., Inc.FMQClass I
K925703Opus Serology ControlsPb Diagnostics, Inc.MJXClass I
K925590Multi-Trauma DressingGam Industries, Inc.NABClass I
K925577Danek Tissue Resecting SystemSofamor Danek Mfg., Inc.HRXClass II
K925289Matrix Cr 2050, Pmi 3000Kulzer GmbHLMCClass II
K925176Vansonnenberg Chest Drainage Catheter All PurposeBoston Scientific CorporationGBXClass I
K924661Swan-Ganz Intellicath Cco Thermodilution CatheterBaxter Healthcare CorporationKRAClass II
K924326Arthrodyn 45 Degree X-Ray TableArthrodyn, Inc.IXRClass II
K924144Endoscopic Carpal Tunnel Release System (Ctr)Davol, Inc.HRXClass II
K924139Glenroe Ortho SepsGlenroe TechnologiesECIClass I
K923995Urodynamics Tubing Kits #5161, #5150, #7170Advanced Medical Products, Inc.FAPClass II
K923419Tismesh SystemTi-Mesh, Inc.JEYClass II
K923408Wrappel TStandard Textile Co., Inc.FRGClass II
K923275Rmhs Monolithic Femoral ComponentSmith & Nephew Richards, Inc.JDIClass II
K922870Three Spike CupOsteo Technology, Inc.GRFClass I
K922660Physio-Dyne Easi - LabPhysio-DyneBZLClass II
K922582Bartels Cytomegalovirus Igg EiaBaxter Diagnostics, Inc.LFZClass II
K922580Bartels Cytomegalovirus Igm EiaBaxter Diagnostics, Inc.LKQClass II
K920843Tooth ConditionerConfi-Dental Products Co.KZPClass II
K915653KeramailWilde-USA, Inc.EIHClass II
K913791Ohmeda 7800 Anesthesia VentilatorOhmeda Anesthesia Systems Therapy GroupBSZClass II
K904380Spinal Cord Access Epidural Introducer SystemCustom Medical Concepts, Inc.MIAClass II
K930997Dominator Radiology SystemDominator Radiology Systems, Inc.LMDClass I