510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3490 of 3526
510(k) clearances, page 3490 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K770766Regulator, Pressure, ExpiratoryGlobe Safety Products, Inc.BYEClass II
K770762Bag, Urinary, Drainage, 2D9013Travenol Laboratories, S.A.KNXClass II
K770753Porta Camera IicGeneral Electric Co.IYXClass I
K770735Dialyzer, Coil, Cd, Lsa, 5M1765Travenol Laboratories, S.A.FHSClass II
K770734Dialyzer, Fiber, HollowTravenol Laboratories, S.A.FJIClass II
K770510Cannula, Intravenous, TeflonSherwood Medical IndustriesFOZClass II
K770458Bilirubin Procedure, Tekpoint Tot & Dir.Icn Pharmaceuticals, Inc.CIGClass II
K770757Pulse/phonocardiography Channel, 144Honeywell, Inc.DQCClass I
K770756Echocardiography Sys., Model 3860Honeywell, Inc.DXKClass II
K770755Echocardiography Sys., Model 3830Honeywell, Inc.DXKClass II
K770508Smac SystemMid Tech, Inc.JCCClass I
K770344Sh-1Delta Medical IndustriesCBNClass II
K770821Pump, Balloon, Intra-Aortic, Tri-SegmentAvco Medical ProductsDSPClass II
K770800Handles, Blade, SurgicalLukens Corp.GESClass I
K770798Blades, Surgical, SterileLukens Corp.GESClass I
K770794Suture Removal Set, SterileLukens Corp.KDCClass I
K770788Echoencephalograph, Digital,digiecho2000Storz Instrument Co.GXWClass II
K770782Fiberscopic Scope Recorder SystemElmed, Inc.GWKClass II
K770768Ophthalmoscope, Model #11100Welch Allyn IncHLIClass II
K770760Monitor, Portable, Patient, G.e.General Electric Co.DPSClass II
K770706Catheter, IrrigationMallinckrodt Critical CareGBXClass I
K770698Counter, SpongeDevon Industries, Inc.
K770666Hemalog 8/90Technicon Instruments Corp.GKLClass II
K770606Analyzeo, Plasma, Blood, ColysagraphDamon Corp.JPAClass II
K770582Lens, Contact, HardBerea Contact Lens, Inc.HPXUnclassified
K770506In Vitro Diagnostic ReagentsNorwood Scientific Associates, Inc.JJCClass I
K770476Exam GownGeneral Medical Co.FMEClass I
K761255Digital ThermometerTexas Instruments, Inc.FLLClass II
K770777Thermometer, Electronic, Digimed HolElmed, Inc.FLLClass II
K770679Chemistry, CoulterCoulter Electronics, Inc.JJEClass I
K770620Tubing Feeding KitDoyle PharmaceuticalFPDClass II
K770547Las-R Tm Human Complement C4 TestHyland Therapeutic Div., Travenol LaboratoriesDAKClass II
K770457Cholesterol Procedure, Tekpoint TotalIcn Pharmaceuticals, Inc.CGOClass I
K770456Phosphorous, Inorganic, Tekpoint DirectIcn Pharmaceuticals, Inc.CEOClass I
K770455Glucose Procedure, Tekpoint DirectIcn Pharmaceuticals, Inc.CGEClass II
K770454Creatinine Procedure, TekpointIcn Pharmaceuticals, Inc.CGXClass II
K770453Phosphatase Procedure, Tekpoint AlkalineIcn Pharmaceuticals, Inc.CIOClass II
K770452Protein Procedure, Tekpoint TotalIcn Pharmaceuticals, Inc.CEKClass II
K770451Albumin Procedure, Tekpoint BromcresolIcn Pharmaceuticals, Inc.CIXClass II
K770450Chloride Procedure, Tekpoint DirectIcn Pharmaceuticals, Inc.CHJClass II
K770449Calcium Procedure, Tekpoint DirectIcn Pharmaceuticals, Inc.CICClass II
K770390Urinalysis ProficiencyMiles Laboratories, Inc.JJWClass I
K761179PsoraliteUltraliteFTCClass II
K770770Wall Charger, Model #79111Welch Allyn IncERAClass I
K770769Otoscope/illuminator, Model #21100Welch Allyn IncERAClass I
K770759Hook HollerDepuy, Inc.KIKClass I
K770536Steam Sterilizer, 3000Castle Co.FLEClass II
K770528Needle, MembraneAmerican ViggoFMIClass II
K770518Piggyback Venoset W/0.22 FilterAbbott MedicalFPAClass II
K770513Mask, Surgical, DispAcme Automatic DisposableFXXClass II