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 2856 of 3529
510(k) clearances, page 2856 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K862158Avp Teleimaging SystemAdvanced Video Products, Inc.LMDClass I
K864474Dental Radiographic 90, Model Pm 2002 Cc PanoramicPlanmeca U.S.A. IncEHDClass II
K864426Raylor(tm) Depth GaugeCedar Surgical, Inc.HTJClass I
K864424Raylor(tm) Protective RetractorCedar Surgical, Inc.GADClass I
K864421Raylor(tm) Periosteal ElevatorsCedar Surgical, Inc.GEGClass I
K864311Sterile Back Gown/stand Back Gown(various Sizes)Clinitech, Inc.FYAClass II
K864306Verinor AlloyDegussa Dental, Inc.EJTClass II
K864210Microselectron-Hdr (High Dose Rate)Nucletron-Oldelft Corp.JAQClass II
K864124Spand-Gel Granulated GelMedi-Tech Intl. Corp.KMFClass I
K863876Omni-FilInpromasEBFClass II
K863647Cards(tm) Strep a Catalog No. Cr-7545Pacific Biotech, Inc.GTZClass I
K863210Velcom-100Waters Instruments, Inc.DPWClass II
K863176Additional Clinical Usages for Osteograf/ar & Ar+Coors Biomedical Co.LYCClass II
K862744Teleradiography SystemE.I. Dupont de Nemours & Co., Inc.LMDClass I
K861905Plotter Model (Mp100)Madsen Electronics (Canada), Ltd.
K864513Lp Arthroscopic Thigh Holding DeviceTwin Falls Orthopedic Associates, P.A.HRXClass II
K864506Spacelabs - Arrhythmia Net (Tm) Level 1Spacelabs, Inc.DSIClass II
K864372Osteonics Mc1 Metal-Back Acetabular Cup/pmma SpaceOsteonics Corp.
K864271Il Test 84673-30 Chromogenics Control PlasmaInstrumentation Laboratory Co.JPAClass II
K864214Il Test 97574-15M, Antitthrombin III AssasyInstrumentation Laboratory Co.JBQClass II
K864213Il Test 97572-15, Alpha 2-Antiplasmin AssayInstrumentation Laboratory Co.LGPClass II
K864116Anago Isolation Mask (#80-950)Anago, Inc.LGMClass II
K864041Emds Theophylline Testpacks Item #67662/95Em Diagnostic Systems, Inc.KLSClass II
K863981Sterilization Wraps #620,624,648,640,636,630,612Graham Medical ProductsFRGClass II
K863646Esophageal Rectal Temperature ProbeRespiratory Support Products, Inc.FLLClass II
K863578Dermatec Zone Transparent DressingDermatec, Inc.NADClass I
K863476Scimed Membrane Oxygenator System - EcmoScimed Life Systems, Inc.DTZClass II
K863231D100 Computer Cardiac Analysis SystemDextra Medical, Inc.DXGClass II
K863230D200 Advanced Computer Cardiac Analysis SystemDextra Medical, Inc.DXGClass II
K8628447.5 Mhz Linear Probe, Cat. No. H4221hGeneral Electric Co.ITXClass II
K862690Traveler LtBio-Logic Systems Corp.GWFClass II
K862685Muscle Master (Bipolar Stimulator)Modern Systems Technology, Inc.IPFClass II
K862450Meda 2500 t.e.n.s.Watlow/Winona, Inc.GZJClass II
K864505Spacelabs Arrhythmia Net (Tm) Level 2Spacelabs, Inc.DSIClass II
K864461Medsurg Custom Cardiovascular Procedure TrayMedsurg Industries, Inc.DWSClass I
K864423Raylor(tm) OsteotomesCedar Surgical, Inc.
K864422Raylor(tm) MalletCedar Surgical, Inc.HWAClass I
K864404Pentron High Strength PorcelainPentron Corp.EIHClass II
K864340Williams Orthopaedic Surgical InstrumentsBuckman Co., Inc.
K864334Acusyst-P (Cell Culture Equipment)Endotronics, Inc.KJHClass I
K864300Siliva Ejector/oral Cavity EvacuatorArdent Intl., Inc.DYNClass I
K864208Vision (Tm) GgtpAbbott MedicalJPZClass I
K864205Thermonuclease Agar W/toluidine BlueRemel IncJSHClass I
K864156Progesterone System by EiaIntl. Bioclinical, Inc.JLSClass I
K864144Luteinizing Hormone (Lh-Irma) Ria KitImmuchem Corp.CEPClass I
K863927CholesterolTech-Co, Inc.CHHClass I
K863925Urea Nitrogen(bun)Tech-Co, Inc.CDQClass II
K863924Uric AcidTech-Co, Inc.KNKClass I
K863923TriglyceridesTech-Co, Inc.CDTClass I
K863921Daig Type O4 Vs-1 ConnectorDaig Corp.DTBClass III