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 2523 of 3531
510(k) clearances, page 2523 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K900860Perfusion MonitorCardio Metrics, Inc.DTYClass II
K900757Itc Angiographic CatheterInterventional Therapeutics Corp.DQAClass II
K896738Type 9293 Interface PulseoxS & W Medico TeknikDQAClass II
K896071Ultra II Porcelain Polishing PasteShofu Dental Corp.EJRClass I
K892514Ahrs Epilator 629American Hair Removal System Co.KCXClass I
K903317Dentalon PlusKulzer GmbHEBGClass II
K903283Argenco IVArgen Precious Metals, Inc.EJTClass II
K903282Argenco 12Argen Precious Metals, Inc.EJTClass II
K903281Argenco 4Argen Precious Metals, Inc.EJTClass II
K903279Argenco 75Argen Precious Metals, Inc.EJTClass II
K903277Argicast BArgen Precious Metals, Inc.EJTClass II
K903276Argenco 33 KfArgen Precious Metals, Inc.EJTClass II
K903275Argenco 36Argen Precious Metals, Inc.EJTClass II
K903232Argenco 5Argen Precious Metals, Inc.EJTClass II
K903118Argenco 7AArgen Precious Metals, Inc.EJTClass II
K903060Argenco 34Argen Precious Metals, Inc.EJSClass II
K903009Argenco IIIArgen Precious Metals, Inc.EJSClass II
K902804Extend Stability Date for Condom W/sperm LubricantOkamoto U.S.A., Inc.HISClass II
K902745Degufill (Tm)Degussa AGEBFClass II
K902413Sonic ScalerDentsply Intl.ELCClass II
K902390Aura Ceramic Dental ApplianceProgressive Technology, Inc.EJFClass I
K901896Endometrial SamplerKirwan Surgical Products, LLCEJFClass I
K901873Degufill (R) Polishing GelDegussa AGEJRClass I
K900678The Myoloc SystemWinder Research, Inc.EJFClass I
K903467Jace Model 100 Knee Cpm DeviceThera Kinetics, Inc.BXBClass I
K903401Special RongeurSur-Med Instruments, Inc.HAEClass II
K903196Image Intensified Fluoroscopic X-Ray SystemGeneral Electric Co.LLZClass II
K902835Fts-100 Fluid Transfer SystemRichard James, Inc.FRNClass II
K902622Manan Prostate Seeding NeedleArgon Medical Devices, IncKXKClass II
K902617Patient Examination GlovesUnicorn Latex, Ltd.LYYClass I
K902601Regent Biogel Diag Proced Gloves Hypoallerg ClaimsRegent Hospital ProductsLYYClass I
K902468Acs One-Stage Prothrombin Time ReagentAnalytical Control SystemsGJSClass II
K902446Disposable Sterile Table Top Cover for HydradjustMallinckrodt Group, Inc.FMWClass I
K902408Diagnostic Ultrasound Ufs 1005Diagnostic Ultrasound Corp.EXYClass II
K902292Modified Assess(r) Peak Flow MeterHealth Products, Inc.BZHClass II
K902281Modified Scoop Transtracheal CathetersTranstracheal SystemsBTOClass II
K902179Vista - Models V12, V20, V23, V38, Ite Hearing AidVista Laboratories, Inc.ESDClass I
K902106Vpw 2877D5, X-Ray Power SupplyVarian Assoc., Inc.IZOClass I
K901888Prostate Probe Surface Coil, Catalog #Bpx-15Medrad, Inc.LNHClass II
K901785Newport Wave Ventilator Model E200Newport Medical Instruments, Inc.CBKClass II
K901640Multicath Placement KitVygon Corp.FOZClass II
K901394Elastyren - Examination and Dental GlovesDanpren Gloves A/SLZAClass I
K901335Aloka Ust-5514Dtu-7.5 Linear Doppler TransducerGE Medical Systems Information Technologies, Inc.DPWClass II
K900505Sonoace 88 Portable Ultrasound ScannerMedison Co., Ltd.HEMClass II
K895243Barnes Femoral Lengthening DevicePiedmont Sports Medicine & Orthopaedic ClinicHRSClass II
K903419Modified Surgiport Disposable Trocar and SleeveUnited States Surgical, A Division of Tyco HealthcGDHClass I
K903259Knowles PinOnyx Medical LLCHWCClass II
K903258Hagie PinOnyx Medical LLCHWCClass II
K903255Cortical Bone Screw (European Style)Onyx Medical LLCHWCClass II
K903254u.s. Type Cruciate Slot Bone ScrewOnyx Medical LLCHWCClass II