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 3289 of 3528
510(k) clearances, page 3289 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811412Neisseria-KwikWindsor Laboratories, Inc.JSXClass I
K811407Ba-93Deringer-Ney, Inc.EJHClass II
K811390Ccs100 Cryosurgical SystemFrigitronics of Connecticut, Inc.GEHClass II
K811382Lab-Tek Jembec G.c. Culture SystemMiles Laboratories, Inc.JTYClass II
K811377Para-PakMeridian Diagnostics, Inc.JTNClass II
K811363Coltene Drs Dental Restorative SystemColtene, Inc.EBFClass II
K811344Behind-the-Ear Hearing AidMaico Hearing Instruments, Inc.ESDClass I
K811303AltracludeR&H Medical, Inc.KDCClass I
K811286Hearing Aid Model E1-PlUnitron Industries, Inc.ESDClass I
K811285Hearing Aid Model E1-PUnitron Industries, Inc.ESDClass I
K811269Glass VialsMedi-Plast Intl., Inc.KPEClass II
K811240Sur-Fit Loop Ostomy o.r. SetE. R. Squibb & Sons, Inc.EXBClass I
K811237Magnetic Retention UnitUniversiti MalayaECGClass I
K811211Yoshida Ap 100Kaycor Intl., Ltd.EGYClass II
K811209Jacob Wirz Transfixation PinColmed, Ltd.ELSClass II
K811172ViconOxford Medilog, Inc.LXJClass II
K811153Coherent Flourotron MasterLumenis LtdHJOClass II
K811145Pneumatic Dental ScalerInnovate, Inc.ELCClass II
K811113Riess-LuhrAllomedicDZAClass I
K810930Bacillum Pumilus Spore StripsOxoid U.S.A., Inc.FRCClass II
K810885#326 Programmable Card. Pulse GeneratorCook Pacemaker Corp.DXYClass III
K810884#325 Programmable Card. Pulse GeneratorCook Pacemaker Corp.DXYClass III
K810707Ceravital Ceramic Ossicular Repl. Pros.Xomed, Inc.ETAClass II
K810605Chematic Bicarbonate Dialysate SystemTrimedyne, Inc.FKRClass II
K811005Corb Tm Counterrotating Biopsy NeedleZimmer GmbHHSZClass I
K811538Models Ta 1017 & 1017T Gritiflo DisposGould, Inc.DRSClass II
K811493Crutch & Walker PadsFred Sammons, Inc.INPClass I
K811492Dressing AdaptorsFred Sammons, Inc.ILDClass I
K811491Wheelchair AccessoriesFred Sammons, Inc.KNOClass I
K811490Forearm & Knee StrapsFred Sammons, Inc.IQIClass I
K811489Scooter BoardFred Sammons, Inc.KNLClass I
K811488Feeding Aid KitFred Sammons, Inc.ILCClass I
K811487Book HolderFred Sammons, Inc.ILPClass I
K811470Lifespan 100Biochem International, Inc.KLKClass II
K811469Mmg Urinary Drainage TubingMedical Marketing GroupKNXClass II
K811467Doxepin/desmethldoxepin/lithiumOrtho Diagnostic Systems, Inc.JJYClass I
K811466Amitriptyline/nortriptyline/lithiumOrtho Diagnostic Systems, Inc.JJYClass I
K811465Imipramine/disipramine/lithiumOrtho Diagnostic Systems, Inc.JJYClass I
K811463Auto-Syringe Micro Volume Extension SetBaxter Healthcare CorporationFPAClass II
K811456Ortho-Frac KitOrthomedicsIQIClass I
K811446Hydron Wound Dressing KitNational Patent Development Corp.KMFClass I
K811440Exp 600 Parallel Plate DialyzerExtracorporeal Medical Specialities, Inc.FJGClass II
K811439Exp 200 Parallel Plate DialyzerExtracorporeal Medical Specialities, Inc.FJGClass II
K811419Sprio-LoopDatamed, Inc.BTXClass I
K811414Baim Coronary Sinus Flow AnalyzerElectro-Catheter Corp.DXGClass II
K811411Swan-Ganz Heparin Coated, Etc. CatheterAmerican Edwards LaboratoriesKRBClass II
K811410Medi-TraceGraphic Controls Corp.KRAClass II
K811408Sterilization Indicator/seal ProtectorBeacon Converters, Inc.JOJClass II
K811403Axicare Breast Pump ModelNeonatal Corp.HGXClass II
K811394Cea Desalting Dolumn Sephadex RImmuno-Diagnostic LaboratoriesDHXClass II