510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 of the 176,466 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
20262,669
176,466 records, page 2660 of 3530
510(k) clearances, page 2660 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K890565Gellhorn Pessary 33410 Various SizesMedi-Source, Inc.HHWClass II
K890494Fluorever Pit and Fissure Sealant or Fluorever PfsMacrochem Corp.EBCClass II
K890435Vitaaccess Catheter Introducer KitVitaphore Corp.FOZClass II
K890290Brace (Orafix Special)Norcliff Thayer, Inc.ECBClass I
K890140Phosphoric-Acid Etching GelCentrix, Inc.EBFClass II
K890139Toitu Doppler Fetus Detector, Fd-400DToitu of America, Inc.KNGClass II
K890012Huntleigh Dynamic Flotation SystemHuntleigh Technology, Inc.FNMClass II
K885205AquadermLaivan Corp.KGXClass I
K885140Multi-Purpose Control SystemColliers Sterilizer Sales & Service Co., Inc.FLEClass II
K884997Ite Hearing Aid Parker/technitone, Model PaHearing Enhancement Center, Inc.ESDClass I
K884796P.f.c.(tm) Modular Knee SystemJohnson & Johnson Professionals, Inc.JWHClass II
K883524Safecon Condoms W/spermicidal LubricantQuality Synthetics Intl, Inc.HISClass II
K8913881570 - Fetal Blood Sampling KitTransidyne General Corp.HGWClass II
K891355Magnesium ReagentMedical Analysis Systems, Inc.JGJClass I
K890997Zavos Disposable Filtration Column (Zdfc)Atlantic Wholesale, Inc.KEAClass I
K890929Kodak Ektachem 750 Series AnalyzerEastman Kodak CompanyJJEClass I
K890928Kodak Ektachem 500 AnalyzerEastman Kodak CompanyJJEClass I
K890927Kodak Ektachem 500/750 Series Analyzer, Soft V1.0Eastman Kodak CompanyJJEClass I
K890897Centurion CirclampCenturion Medical Products, LPHFXClass II
K890802Cotube(tm) Tsh IrmaBio-RadJLWClass II
K890549Ventrex Coated Tube HcgVentrex Laboratories, Inc.JHIClass II
K890412Models 430-07 & 431-07 Implantable Pacing LeadsIntermedics, Inc.DTBClass III
K890411Models 432-03 & 433-03 Implantable Pacing LeadsIntermedics, Inc.DTBClass III
K890066Star 36Transworld X-Ray Corp.IZOClass I
K885272Cholinesterase Reagent, Dibucaine & FluorideSigma Chemical Co.DIHClass I
K885267Vs-1 Model Number 251K Pulse GeneratorPacesetter SystemsDXYClass III
K885263Qms(tm) - TheophyllineSeradyn, Inc.JQXClass I
K885203Technicon Dax(tm) SystemTechnicon Instruments Corp.JJGClass I
K884184Sigma Procedure No. 465 for Deter. of FructosamineSigma Diagnostics, Inc.LCPClass II
K890840Visuwell Group a Streptococcus Detection KitAdi Diagnostics, Inc.GTZClass I
K890530N Latex Ige Kit (Immunoglobulin E Reagents)Behring Diagnostics, Inc.DGCClass II
K890422Abbott Testpack(tm) D-DimerAbbott MedicalGHHClass II
K890288Peritoneal Catheters with an Added FunctionQuinton, Inc.FJSClass II
K884831Anaerobic Mic PanelMicrotech Medical Systems, Inc.JWYClass II
K884612Franklin Collector(r)Franklin Diagnostics, Inc.FQZClass I
K883399Ubi Magiwel Cmv Igg QuantitativeUnited BiotechLFZClass II
K880433Cytomegalovirus Igg Eia KitDe Ferris Laboratories, Inc.LFZClass II
K891434Patient Examination Gloves (Latex)Sime Darby USALYYClass I
K891424Patient Examination Gloves (Latex)Oon Corp. ResourcesLYYClass I
K891120Texmed Latex Examination GloveTranscorpLYYClass I
K890908Stratus(r) II Fluorometric Analyzer & AccessoriesBaxter Healthcare CorporationKHOClass I
K890865Hexascan Scanner HandpieceMetatech Corp.GEXClass II
K890787O-020 Laser Indirect OphthalmoscopeHgm Medical Laser Systems, Inc.HGFClass II
K890573Kenlor Total Iron, Uibc/tibc Assay KitKenlor Industries, Inc.JIYClass I
K890521Abbott Clinical Chemistry Reagent AlpAbbott MedicalCJEClass II
K890510Abbott Ovulation Predictor TestAbbott MedicalCEPClass I
K890509Indirect Ophthalmoscope Accessory Delivery SystemBiophysic Medical, Inc.HQFClass II
K890462Latex Examination GloveC.R. Trading, Inc.LYYClass I
K890312Gamma-GlutamyltransferaseAmerican Monitor Corp.JQBClass I
K884974Accessory to Eyedrop GuideSuredrop, Inc.JYJClass I