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 2904 of 3529
510(k) clearances, page 2904 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K860260Multi Purpose Model 76-903Victoreen, Inc.LHOClass I
K860025Model Ms-325 Radiographic X-Ray GeneratorMedicor USA, Ltd.KPRClass II
K854976Rmi Respiratory Gating System Model 301Radiation Measurements, Inc.IXOClass I
K854840Physiological Monitor, Models 101,301,201,202,303AIvy Biomedical Systems, Inc.DPSClass II
K854596Tdk ECG Electrode Mel-08-09 & -11Tdk Corp.DRSClass II
K854431Meadox Medicals Inc. Graft SizerMeadox Medicals, Div. Boston Scientific Corp.DSYClass II
K853996Disposable Pressure Transducer System SterileTransamerica Delaval, Inc.DRSClass II
K853754Magnetic Resonance Imaging Uniformity/t1 76-901Victoreen, Inc.LHOClass I
K853567Djp UnipolarBiotronik Sales, Inc.DTBClass III
K853566Dj UnipolarBiotronik Sales, Inc.DTBClass III
K861525Disposable Surg Kits/gowns/guards/covers/masksD & D Products, Inc.FSMClass I
K861490Permaclear Solution Cat. No. 4950Helena Laboratories, Corp.KEMClass I
K861488Companion 2800 Volume Ventilator Remote AlarmMedtronic, Inc.CBKClass II
K861480Charcoal Agar BaseGibco Laboratories Life Technologies, Inc.JSGClass I
K861473Model 63-654 Thermometer, Electronics, ClinicalRadio Shack Div. Tandy Corp.FLLClass II
K861463Shiley Sleep Apnea Low Pressure Cuffed Trach TubeShiley, Inc.BTRClass II
K861462Shiley Sleep Apnea Cuffless Tracheostomy TubeShiley, Inc.BTRClass II
K861461Shiley Sleep Apnea Cuffless Fenestrated Trach TubeShiley, Inc.BTRClass II
K861454End Tidal CO2 TubeSheridan Catheter Corp.BTRClass II
K861453Stagnone Swivel-Joint NeedleRadtech, Inc.
K861446S1 Oral PackingSurgical Specialties CorpEFQUnclassified
K861445S1 Cavity PackingSurgical Specialties CorpEFQUnclassified
K861444S1 Nasal PackingSurgical Specialties CorpEFQUnclassified
K861443S1 Vaginal PackingSurgical Specialties CorpEFQUnclassified
K861439Churchill Female Luer Lock CapChurchill Corp.FPAClass II
K861432Veolar VentilatorHamilton Medical AGCBKClass II
K861406Non-Kor Winged Infusion SetsCreative Care Systems, Inc.FMIClass II
K861398Pre-Check C02 DetectorAlleghany Intl. Medical TechnologyCCKClass II
K861365Fasiculated NailLake Region Mfg., Inc.HSBClass II
K861288Non-Sterile & Sterile Disposable Surgical DrapesProcedure Pak, Inc.KKXClass II
K861163Xtal X-800 ShadowgraphXtal Corp.
K861152Exel Vacuum Blood Collecting SystemExel Intl.FMIClass II
K861101The New Flexible Collapsible ChamberStephenson Industries, Inc.KPJClass II
K861060Site Phaco Disposable CassetteSite Microsurgical Systems, Inc.HQCClass II
K861036E7509 Polyhesive II Patient Return ElectrodeMedtronic, Inc.GEIClass II
K861027Keta Hand-Held TonometerKeta Corp.HKSClass I
K860989Site Disposable CassetteMicrosurgical Systems, Inc.HQCClass II
K860969Fluid Management System (Modified)Haemonetics CorporationFRNClass II
K860949Dual-AidVitalograph, Inc.CAEClass I
K860781ICU Medical Needle, Lopez NeedleAbbott MedicalFMIClass II
K860753Sensititre Susceptibility PlatesGibco Laboratories Life Technologies, Inc.JWYClass II
K860703U - Star (Micro-Star)Corning Costar Corp.LHIClass II
K860474Stream Line* i.v. Catheter Placement UnitMenlo Care, Inc.FOZClass II
K860442Precision Hip System Proximal Femoral Spacer #6259Howmedica Corp.LPHClass II
K860438Newport Ventilator Model E-100Newport Medical Instruments, Inc.CBKClass II
K860277Model 525-25 Watt C02 Laser for Ear, Nose & ThroatBritt Corp., Inc.EWGClass II
K855237Biotel (Tm)/ KidneyAmerican Diagnostic Corp.KHEClass II
K855084Premie T.d.s. Electrosurgical Grounding PadConmedcorpGEIClass II
K861569Ultraclone 01-700 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K861409Syncare Temporary Cardiac Pacing WireGyneco, Inc.LDFClass II