510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3124 of 3528
510(k) clearances, page 3124 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K833116Spirit Chemistry SystemBaker Instructions Corp.JJEClass I
K833074Castle Tec-Test S.m.a.r.t. PackCastle Co.JOJClass II
K833069Tdx GlucoseAbbott MedicalCGAClass II
K833061C-Flex Penrose Drainage TubeConcept, Inc.FFAClass II
K833036Flow-Pac Sodium Reagent SetAmerican Research Products Co.JGSClass II
K833034Universal Vented & Non/volume Infus-YFPAClass II
K833033Infusion Set-52-05-1 20 Drops-Mi VolYFPAClass II
K832990Stifnick Immobilizing CollarLaerdal California, Inc.IQKClass I
K832942Total & Direct Bilirubin ProceduresSandare Chemical Co., Inc.CIGClass II
K832940RotagymI-Rep, Inc.ISDClass II
K832920Intermittent Compression PumpsChattanooga Group, Inc.IRPClass II
K832913Back Massager B-400 AdjustablePollenex Associated Mills, Inc.ISAClass I
K832693Arrhythmia III Cardule #1919Spacelabs, Inc.DSIClass II
K832657Disposable Manifold SetMallinckrodt Critical CareDRSClass II
K832656Dinamap Vital Signs Monitor #1846PCritikon Company, LLCDXNClass II
K831134Phoenix 60/60 Processor ModulePhoenix Corp.DSFClass I
K831391Shot Gun Kit for Ck-MbSerapine Corp.JHTClass II
K833444Lysing & Hemoglobin S-Reagent J & SJasins & Sayles Associates, Inc.GGKClass I
K833443Isotonic Blood Cell Diluent J & SJasins & Sayles Associates, Inc.GIFClass I
K833437Orthopedic StockinetteNorthern Medical Surgical, Inc.ILGClass I
K833424Veigert's Iron Hematoxylin Stain-Ht10-79Sigma Chemical Co.HYOClass I
K833394Medium 199 W/hank's Salt W/l-GlutamineSigma Chemical Co.KITClass I
K833393Iscoe's Mod. Dulbecco's Med. W/glutamSigma Chemical Co.KITClass I
K833392Waymouth Mb 752/1 Med. W/l-GlutamineSigma Chemical Co.KITClass I
K833391Lactalbumin Hydrolysate Med. W/hanksSigma Chemical Co.KITClass I
K833390Tyrode's Salt Solution W/sodium BicarSigma Chemical Co.KITClass I
K833389Medium 199 W/earle's Salts W/l-GlutamSigma Chemical Co.KITClass I
K833374Bite-BlockSontek Industries, Inc.JAYClass I
K833373Bodia Bronch-Saf Double SwivelSontek Industries, Inc.BZAClass I
K833372Bodia Trach-Saf Double SwivelSontek Industries, Inc.BZAClass I
K833361Tube-TitleSontek Industries, Inc.JAYClass I
K833360Hep-2 CellsBiocon, Inc.KIRClass I
K833359Wi-38 CellsBiocon, Inc.KIRClass I
K833358Mrc-5 CellsBiocon, Inc.KIRClass I
K833356Glyco-Je,e Cpmtrp;-Normal/abnormalHelena Laboratories, Corp.LCPClass II
K833352Gen. Diagnostics Low Fibrinogen ControlWarner-Lambert Co.GILClass II
K833343Sterilization ContainerMedin Corp.FRGClass II
K833326Mini Ox III Oxygen MonitorCatalyst Research Corp.BXLClass I
K833319Bio-Rex 70 Resin 100-200 Mesh Ph6.2Biosan Laboratories, Inc.KEAClass I
K833272Thromboplastin - FsAmerican DadeJPAClass II
K833264Adler Steam Indicator-Gas IndicatorAdler Instrument CompanyJOJClass II
K833196Volume Ventilator Circuit-NebulizerAirlife, Inc.CAIClass I
K833127Argyle Nasal CannulaSherwood Medical Co.CATClass I
K833096Transducer Dome Ds106Sorensen ResearchDRSClass II
K833095Transducer Dome Sd105Sorensen ResearchDRSClass II
K833094Transducer Dome Sd104Sorensen ResearchDRSClass II
K833060Model Cd-3A-Including P-61B SensorApplied Electrochemistry, Inc.CCKClass II
K833035Calcium Dye Reagent-Cs-718-A/bufferFisher Scientific Company L.L.C.CICClass II
K833030Intravascular Administration SetGish Biomedical, Inc.FPAClass II
K833023Technicon Ra-1000 SystemTechnicon Instruments Corp.JJCClass I