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 3443 of 3526
510(k) clearances, page 3443 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K780700Lundia Plate Disposable DialyzerGambro, Inc.FJGClass II
K780574Suture CutterLaschal Instrument Corp.FZTClass I
K780484Silastic Brand Penile ImplantDow Corning Corp. Healthcare Industries MaterialsFIQClass II
K781082Cast BlockOrthopedic Equipment Co., Inc.JEBClass I
K781080Galvanator, Model 770Avra Corp.IPFClass II
K780565Sutureless Skin ClosureAbbott MedicalFPXClass I
K780421Generator, Pulse, Cardiac, ImplantableTelectronics, Inc.DXYClass III
K780957Set, Administration, Manual, DialysisAmerican Medical Products LLCKDJClass II
K781044Ultrasonic Dental Prophylaxis Unit,ssmLitton Dental ProductsELCClass II
K781035Periodontal Instrument #21 Goldman-FoxPremier Dental Products CoEMNClass I
K781034Premier Inlay PlacerPremier Dental Products CoEKIClass I
K781018Dx ToothbrushLever Brothers Company, Inc.EFWClass I
K781007Auto-ConBarnes-Hind, Inc.HPXUnclassified
K781001Chairs with CastorsOrthopedic Equipment Co., Inc.INMClass I
K780994Cervical CollarFox Instruments, Inc.IQKClass I
K780979Airstirrup Pneumatic Ankle BraceAircast, Inc.IQIClass I
K780929Cotton Tipped PointYoung Dental Manufacturing Co 1, LLC.KXFClass I
K780898Instant Cure-1Ultra-Light Corp.EBZClass II
K780880Y-Type Blood SetAbbott MedicalKDCClass I
K780851Charles Endocoagulator Accessory for ArcVarian Assoc., Inc.HOBClass I
K780823Contact Lens CleanserKetchum Laboratories, Inc.HPXUnclassified
K780814Safety Stop NeckstrapNorthwest Orthodontics, Inc.DYTClass I
K780780Micropulse 22S PacemakerEdwards Pacemaker SystemsDXYClass III
K780761Electro-PlethysmographBiotecx Laboratories, Inc.JOMClass II
K780717External Test Pulse GeneratorVitatron Medical BVDTCClass II
K780564FecatestOtto C. WatzkaKHEClass II
K780453Stanicor Theta Model 221 Cardiac PacerCordis US Corp.DXYClass III
K781049Acu-Test in-Home Pregnancy TestWilliams, the J.B. Co., Inc.JHJClass II
K781041Electroencephalograph Accutrace 100Beckman Instruments, Inc.GWQClass II
K781033Hearing AidPhonemics, Inc.ESDClass I
K781029Otoscope, Diag. Models 20100 & 20200Welch Allyn IncERAClass I
K781008Isotonic DiluentMallinckrodt Critical CareGIFClass I
K781005Electroencephalograph Accutrate 200Beckman Instruments, Inc.GWQClass II
K780931Soft Lens InserterSoft-SertKYEClass I
K780912Adjustable DispensorOxford Laboratories, Inc.JQWClass I
K780911Sysmex Platelet Counter, Pl-110Toa Medical Electronics USA, Inc.GKLClass II
K780910System Auto. Blood Cell Counter Cc-110Toa Medical Electronics USA, Inc.GKLClass II
K780909Sysmex Auto. Blood Cell Counter, Cc-120Toa Medical Electronics USA, Inc.GKLClass II
K780903Clinical Analyzer SystemBausch & Lomb IncorporatedJJQClass I
K780902Fisher SpectrophotometerBausch & Lomb IncorporatedJJQClass I
K780901Automated Electrophoresis SystemOlympus Corp.JQTClass I
K780888Thermo Set Electronic Tem. ControllerGilford Instrument Laboratories, Inc.JRIClass I
K780882Diluter/dispenserInnovative Medical Systems, Inc.JQWClass I
K780813Idi Gdr Data Reduction SystemIso-Data, Inc.
K780718Sof-Wicklap PadJohnson & Johnson Professionals, Inc.GDYClass I
K780619Preformed Tooth PositionerTp Laboratories, Inc.KMYClass I
K780597ECG Paper, 3 ChannelAbco Dealers, Inc.DSFClass I
K780460Dental Air BrushM. Joel Gebhart, D.D.S.KOHClass I
K780438Safety Spring Guides, Teflon CoatedC.R. Bard IncDQXClass II
K780352Immunozyme Toxoplasma AntibodyEMD Millipore CorporationGLZClass II