510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 2525 of 3531
510(k) clearances, page 2525 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K902783Ps Medical Delta Csf-Flow Control ValvePudenz-Schulte Medical Research Corp.JXGClass II
K902729R.p.i. Gravity Safe Feeding BagRidge Products, Inc.KNTClass II
K902415Vision Jantzen SunglassesVision Products Co., Inc.HQYClass I
K902221Modified Angiographic Injector and SyringeMallinckrodt Group, Inc.DXTClass II
K902207Acs .010 Hi-Torque Inter. and Standard Guide WireAdvanced Cardiovascular Systems, Inc.DQXClass II
K902187PolaronNurion IndustriesHPGClass I
K902088Modified Software to the Sonos 100 UltrasoundHewlett-Packard Co.DPWClass II
K902033Magic Hot Shades 70116, 70118, 70119Nationmark, Inc.HQYClass I
K901887Modified Sepacell R-Series Blood FiltersAsahi Kasei Medical MT Corp. Oita WorksCAKClass II
K901846Ohmeda - Logic 07A Transport VentilatorGE HealthcareBTLClass II
K901795Gastrostomy Feeding CatheterSouthside BiotechnologyKGCClass II
K901791Percutaneous Endoscopic Gastrostomy Feeding Cath.Southside BiotechnologyKGCClass II
K9017773M First Aid Bandage for Minor Wounds3M CompanyKGXClass I
K901671Hafcon (Flouro Footswitch)B & H Research InstrumentsJAAClass II
K900756Itc Introducer CatheterInterventional Therapeutics Corp.DYBClass II
K900645Laserdish Polyurethane Ventricular Lead W/trailingTelectronics Pacing Systems, Inc.DTBClass III
K896824Biotronik's Ps-Endocardial LeadsBIOTRONIK AGDTBClass III
K895644Cadd-Pca Ambulatory Infusion PumpsPharmacia Deltec, Inc.FRNClass II
K894560Qsi 9000Quantified Signal Imaging, Inc.GWFClass II
K903069Kleartex Latex Surgical GlovesTranscorpKGOClass I
K902665Argenco Y (Type Iii/iv Dental Alloy Crown/bridgeArgen Precious Metals, Inc.EJSClass II
K902642Contorno (Tm)Palex Intl. SAGEIClass II
K902502Byrd Stainless Steel DilatorMedical Engineering and Development InstituteGCCClass I
K902400Wilson-Cook Retrieval & Grasping ForcepsWilson-Cook Medical Inc.OCZClass II
K901464Medilase Series 2200 EndoscopeMedical Laser, Inc.GCMClass II
K903280Argenco 27Argen Precious Metals, Inc.EJTClass II
K903278Argenco 28Argen Precious Metals, Inc.EJTClass II
K903274Argenco NordicArgen Precious Metals, Inc.EJTClass II
K902966Argenco 2 Type III Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K902908Accuprobe Streptococcus Pneumoniae Culture Confir.Hologic, Inc.MCTClass I
K902902Argenco 6 Type II Dental Gold AlloyArgen Precious Metals, Inc.EJTClass II
K902830Peri-BottleOrion Life Systems, Inc.HEDClass I
K902556Acs Activated Partial Thromboplastin Time TestAnalytical Control SystemsGFOClass II
K902213Accuprobe Staphylococcus Aureus Culture Confirma.Hologic, Inc.MCSClass I
K902120Mercury RhinomanometerLife-Tech Intl., Inc.BXQClass II
K902108Hem-O-Lok(tm)Edward Weck, Inc.FZPClass II
K902075Intrigue Ceramic BracketLancer Orthodontics, Inc.NJMClass II
K902068Hearing Ambassador-Hear Pen Screening AudiometerStarkey Laboratories, Inc.EWOClass II
K902064Modified Uni-Stick Plastic LigatureAmerican OrthodonticsEJFClass I
K901977Beckman Antithrombin III Reagent KitBeckman Instruments, Inc.JBQClass II
K901871Degufill (R) AdhesiveDegussa AGKLEClass II
K901870Degufill (R) BondDegussa AGKLEClass II
K901344Medela Battery Operated Breast PumpMedela AGHGXClass II
K897053L'll Squirt Gum Oral Rinse DeviceJames R. PowellEFSClass I
K896750Lofric(r), Lofric(r) Cath-KitAstra Meditec ABKODClass II
K894506Entera-Flo Enteral Feeding PumpDelmed, Inc.FRNClass II
K902927Digital PhotospotEigenJAAClass II
K902849Philips VeriflexPhilips North America LLCIYEClass II
K902637Futurus 2001 X-Ray GeneratorAcoma Medical Imaging, Inc.IZOClass I
K902314Large Flexible Body CoilToshiba America Mri, Inc.LNHClass II