510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 3357 of 3526
510(k) clearances, page 3357 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K800884Cardiacs II Toxicology ControlUtak Laboratories IncDIFClass I
K800883Cardiacs I Toxicology ControlUtak Laboratories IncDIFClass I
K800882Anticonvulsants Toxicology ControlUtak Laboratories IncDIFClass I
K800868Ferro-Quant Tm Fe 59 Test KitMallinckrodt Critical CareJQGClass I
K800860Omnistik, Mq 501GsMarquest Medical Products, Inc.CBTClass I
K800856A,fda2 Lyophilized Hemo ControlHelena Laboratories, Corp.JBDClass II
K800855A,fsc Lyophilized Hemo ControlHelena Laboratories, Corp.JBDClass II
K800854A,a2 Lyophilized Hemo ControlHelena Laboratories, Corp.JBDClass II
K800853A,sa2 Lyophilized Hemo ControlHelena Laboratories, Corp.JBDClass II
K800828Myerson's Special Crown & Bridge ResinMyerson Tooth Corp.EBGClass II
K800827Premier Absorbent PointsPremier Dental Products CoEKNClass I
K800823Quick FillMedrad, Inc.DXTClass II
K800794Fast Hemoglobin Control-LyophilizedIsolab, Inc.LCPClass II
K800784Minuet Masker; Jubilee MaskerBeltone Electronics Corp.KLWClass II
K800778Digital Electronic B.p. Monitor 2155Sears, Roebuck & Co.DXNClass II
K800764Drager OrmcDraeger, Inc.BZRClass II
K800754Nickerson's Med. Selective Culture MediuOrtho Pharmaceutical Corp.JSJClass I
K800747Beltless Maxi, Mini & Super Maxi PadsDafoe & Dafoe, Inc.HHDClass I
K800722Auto-Field D Automated Visual DetectorCavitron Corp.HPTClass I
K800622Extension LineNorton Performance Plastics Corp.DQOClass II
K800567Radioear Model Rm-L & Rm-C Hearing AidRadioear Corp.ESDClass I
K800560Mx820-5 Pressure Infusor 500Cc Mx820-10Medex, Inc.KZDClass I
K8004873M Titanium Alloy Total Hip System 32Mm3M CompanyJDIClass II
K800440Sterile Sponge BowlsPremium Plastics, Inc.FNYClass I
K800159Phadebact Strep D TestPharmacia, Inc.GTZClass I
K800418Adt Disposable Thin Needle AspirationA.D.T. Lab IndustriesFSMClass I
K800417Adt Ptc Pro. Tray W/(skinny Chiba) NeedlA.D.T. Lab IndustriesGAAClass I
K800414Adt Soft Tissue Biopsy TrayA.D.T. Lab IndustriesGAAClass I
K800412Rosenthal Needle (Disp.) Adt Bone MarrowA.D.T. Lab IndustriesGAAClass I
K800411Aspiration Tray W/ferris Disp. IllinoisA.D.T. Lab IndustriesGAAClass I
K800410Adt Bone Marrow Biopsy-Aspiration TrayA.D.T. Lab IndustriesGAAClass I
K800409Adt Bone Marrow Biopsy Aspiration TrayA.D.T. Lab IndustriesGAAClass I
K800408Adt Bone Mar. Bio/asp. Tray W/needleA.D.T. Lab IndustriesGAAClass I
K800895Model 253-11 Cyberlith Pulse GeneratorIntermedics, Inc.DXYClass III
K800851Series 602 Ckgtm RecorderCardio Kinetics, Inc.DSFClass I
K800848Seralyzer Uric Acid Reagent Strips -Miles Laboratories, Inc.KNKClass I
K800836Kma Flow Directed Thermodilution CatheteKma, Inc.KRBClass II
K800821Aft Tm System Antimitochondrial AntibodyCalbiochem-Behring Corp.DBMClass II
K800820Aft Tm System Antismooth Muscle AntibodyCalbiochem-Behring Corp.DBEClass II
K800818Chlamydospore AgarIsle Media and Sterile Products, Inc.JSHClass I
K800813Diagnostic Products Corp. Ria ControlSiemens Healthcare Diagnostics Inc.JJYClass I
K800812Medi-ThermGaymar Industries, Inc.DWJClass II
K800807Corn Meal Agar MediaIsle Media and Sterile Products, Inc.JSJClass I
K800798Human Thyroid Stim. Hormone/aria IIBD Becton Dickinson Vacutainer Systems PreanalyticJLWClass II
K800796Gas Pak II Dis. Generator EnvelopesBD Becton Dickinson Vacutainer Systems PreanalyticKZJClass I
K800780Sandare Lyophilized Hemoglobin ControlsSandare Chemical Co., Inc.JPKClass II
K800773Digoctk 125Sorin Biomedica, Fiat, USA, Inc.LCSClass II
K800769Y-Gt Test, Y-Glutamyl Transferase TestSclavo, Inc.JQBClass I
K800767Mod. Mci 17 Manual Cuff InflatorMedasonics, Inc.DXQClass II
K800766Echo-CompDigisonics, IncDQKClass II