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 2455 of 3531
510(k) clearances, page 2455 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K911198Tibial Tray Pmma Plug for Plus/axiom Total Knee SyOrthomet, Inc.JWHClass II
K911197Plus Total Knee Syst/axiom Total Knee SystemOrthomet, Inc.JWHClass II
K910919Abbott Lifecare 5000 Pump ModifiedAbbott MedicalFRNClass II
K910869Howmedica(r) Cemeted Femoral ComponentHowmedica Corp.JDIClass II
K910858Stryker Arthroscopic Infusion PumpStryker Corp.HRXClass II
K910794Small Instrument Sterilization/bur BoxBrevet Inc.EJLClass I
K910767Tl100w/01 Uvb LampPhilips Lighting Co.FTCClass II
K910584One Step Button(tm)Applied Medical TechnologiesKGCClass II
K910563P.f.c.(r) Modular Knee Syst, Stab All-Plast TibialJohnson & Johnson Orthopaedics, Inc.JWHClass II
K905779AldetectPochemco, Inc.FJIClass II
K904870Modified New Jersey Femoral Hip Resurfacing ComponEndotec, Inc.KXAClass II
K904355Cardiocap II Tm Ch-Resp MonitorsInstrumentarium Corp.DPSClass II
K911766Sunglasses-Nonprescription Including Photosen.Gall'S, Inc.HQYClass I
K911755Control for Ph,blood Gases,eletrolytes,glucoseBionostics, Inc.JJYClass I
K911724Aca(r) Urine Drugs of Abuse Control, ModificationE.I. Dupont de Nemours & Co., Inc.DIFClass I
K911519Cathcap, Cat. No. Cc100 SeriesGish Biomedical, Inc.DQYClass II
K911512Milenia ProgesteroneSiemens Healthcare Diagnostics Inc.JLSClass I
K911406Hdl Cholesterol ReagentGenzyme CorporationLBRClass I
K911092Osmometer Model 2400Advanced Instruments, LLCJJMClass I
K911062Qualitative Keratometer M823 with Power SupplyStorz Instrument Co.HNOClass I
K910980Site 20 Gauge Reusable Fiber Optic CableSite Microsurgical Systems, Inc.HJOClass II
K910239Nebu-Sol Metered Dose Dispenser (Tm)Dey Laboratories, Inc.BSYClass I
K910178Acth Irma Kit Mitsubishi YukaScience Regulatory Services Intl.CKGClass II
K910021Cardiopulmonary Bypass Pump TubingJtl Medical Corp.DWFClass II
K904789Series 7000 Carbon Dioxide ModuleMarquette Electronics, Inc.CCKClass II
K904200Spirosift 500AFukuda Denshi USA, Inc.BZGClass II
K911950Medi Guard DrapesSancella, Inc.KMEClass I
K911601Reddick Trocar and CannulaIdeal Medical, Inc.FSMClass I
K911327Cell SweepReza S Mohajer, M.D. C/O Krass & YoungHHTClass II
K911289Epidural Indication for Baxter Syringe Infus PumpBaxter Healthcare CorporationFRNClass II
K910845Itc Rotating Hemostatic Valve Cat. No. Mx 1012Interventional Therapeutics Corp.DTLClass II
K910736Jackson Multipurpose Operating TableMizuho Orthopedic Systems IncJEAClass I
K910712Villan (Video Lift Link Analysis)Physio Systems, Inc.LXIClass I
K910708Rich-Mar Model X Ultrasound Therapy DeviceRich-Mar Corp.IMIClass II
K910491Wallach Cold SoakerCooperSurgical, Inc.GEHClass II
K910073Target Aso TestTexas Immunology, Inc.GTQClass I
K905803Hale Sun Surgical Towel or o.r. TowelHale Sun Industries, Ltd.KKXClass II
K905258S-Rom Oblong Acetabular CupJoint Medical Products Corp.JDIClass II
K904934AutomasterTeam Mfg., Inc.IPQ
K904650Wheelchair Conversion KitHadco Marketing Services, Inc.ITIClass II
K911622CPR BagMerced Medical, Inc.BTMClass II
K911397Hypodermic Needles, Single LumenPopper & Sons, Inc.FCGClass II
K911080Hygiena-TrachApdyne Medical Co.JOHClass II
K910909MucaidVygon Corp.BSYClass I
K910908Mucaid with Suction Catheter and Extension TubingVygon Corp.BSYClass I
K910800Adp ReagentHelena Laboratories, Corp.GHRClass II
K910706Collagen Reagent Cat. No. 5368Helena Laboratories, Corp.GHRClass II
K910680Epinephrine Reagent, Cat. No. 5367Helena Laboratories, Corp.GHRClass II
K905789Franklin 9000 Wall StandMallinckrodt Group, Inc.KPXClass II
K904253Ortho Mune Okt3,4, and 8 Monoclonal AntibodyOrtho Diagnostic Systems, Inc.GKZClass II