510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 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 3294 of 3528
510(k) clearances, page 3294 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811177Quanta Phase Vitamin B-12/Folate RadBio-RadCGNClass II
K811176Tigges SpinalThe Tiggs Co.IPWClass I
K811169Prostatic Acid Phosphatase (Pap) Rda KitAmersham Corp.JFHClass II
K811152Dade Rpr Card TestAmerican DadeGMQClass II
K811151Collarless Total Hip Femoral Comp. SysHowmedica Corp.JDIClass II
K811150Urine Pregnancy Test Standard/contr. PkMallinckrodt Critical CareJJXClass I
K811144Aria II Insulin RiaBD Becton Dickinson Vacutainer Systems PreanalyticCFPClass I
K811015Positive Closure Anesthetic ValveMizuho Orthopedic Systems IncCAIClass I
K811011Histochemical Demonstration of LeukocyteSigma Chemical Co.GIAClass I
K810937Anis Irrigating SpatulaAmerican V. MuellerHNDClass I
K810894Fogarty Flexible CalibratorAmerican Edwards LaboratoriesDWPClass II
K810808Coratomic Model Ovalith-920Coratomic, Inc.DXYClass III
K810734Models 8420 Thru 8423 Pacemaker GenerMedtronic, Inc.DXYClass III
K810399Apc Implantabel Pacing Lead, Model 3264American Pacemaker Corp.DTBClass III
K810398Apc Implantable Pacing Lead, Model 3266American Pacemaker Corp.DTBClass III
K810397Apc Implantable Pacing Lead-Flange #3260American Pacemaker Corp.DTBClass III
K810396Apc Implantable Pacing Lead, Tined #3262American Pacemaker Corp.DTBClass III
K810043Goat Anti-Herpes Simplex Virus Type IVibac Corp.GQMClass II
K811236Disposable Holder for Hancock AorticVascor, Inc.DTJClass I
K811235Disposable Holder for Hancock MitralVascor, Inc.DTJClass I
K811226Dahlberg Model AmDahlberg Electronics, Inc.ESDClass I
K811181Model Fbs-1, Flexible BronchoscopeAmerican Optical Corp.EOQClass II
K811174Hearing Aid, Unitron Model C5-HUnitron Industries, Inc.ESDClass I
K811154Hoyt Econo-TrayHoyt LaboratoriesKMTClass I
K811143Ph/blood Gas Control (Abc)Instrumentation Laboratory Co.JJSClass I
K811116Hcg RadioimmunoassayHoffmann-La Roche, Inc.JHIClass II
K811075Balance ArticulatorAlmore Intl., Inc.EJPClass I
K811033Shiley Low Pressure Thin-Cuffed TrachShiley, Inc.BTOClass II
K810977Endodontic Post SystemsPreat Corp.ECGClass I
K810974Gamma CameraSiemens Gammasonics, Inc.IYXClass I
K810895Esophageal Pill ElectrodeCon Med Equipment, Inc.DRXClass II
K810868Araluen Head ShieldAraluen, Inc.FPPClass I
K810858Ximatron VSiemens Corp.KPQClass II
K810783Alsever's Solution (Modified)Dutchland Laboratories, Inc.KITClass I
K810782Trypan Blue (0.5% in Normal Saline)Dutchland Laboratories, Inc.LGYClass I
K810781L-GlutamineDutchland Laboratories, Inc.KITClass I
K810780Sodium Bicarbonate (7.5%) SolutionDutchland Laboratories, Inc.KITClass I
K810779Earle's Balanced Salts SoultionDutchland Laboratories, Inc.KIPClass I
K810778Basal Medium Eagle (Mod.) W/earle's SaltDutchland Laboratories, Inc.KITClass I
K810776Penicillin-Streptomycin MixtureDutchland Laboratories, Inc.KITClass I
K810774Water-Tissue Culture GradeDutchland Laboratories, Inc.KITClass I
K810773Basal Medium Eagle W/hanks' SaltsDutchland Laboratories, Inc.KITClass I
K810772Medium 199 W/earle's Salts & GlutamineDutchland Laboratories, Inc.KITClass I
K810771L-15 Medium (Modified)Dutchland Laboratories, Inc.KITClass I
K810770Med. 199(Modified) W/hanks' SaltsDutchland Laboratories, Inc.KITClass I
K810769Minimum Essential Medium Eagle W/earleDutchland Laboratories, Inc.KITClass I
K810768Minimum Essential Medium Eagle W/hanksDutchland Laboratories, Inc.KITClass I
K810641K-Med Encourager Incentive SpirometerK-Med, Inc.BWFClass II
K810584Phadebas Isoamylase TestPharmacia, Inc.CIWClass II
K810403Keeler/konan Specular MicroscopeKeeler Optical Products, Ltd.HJOClass II