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 1651 of 3531
510(k) clearances, page 1651 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K002290Abl-700 Series, Model Abl 7Xx (Various Models)Radiometer Medical ApSCHLClass II
K002087Bestex Powder-Free Latex Exam Gloves with Labeling Claim. (50 Micrograms or Less)Qingdao Bestex Rubber & Plastic Products Co., LtdLYYClass I
K000145Midas Touch Blue Nitrile Examination Gloves-Powder FreeIndustrial Clothings, Ltd.LZAClass I
K000143Midas Touch Nitrile Examination Gloves-PowderedIndustrial Clothings, Ltd.LZAClass I
K000142Midas Touch Latex Examination Gloves-Powder FreeIndustrial Clothings, Ltd.LYYClass I
K000141Midas Touch Latex Examination Gloves-PowderedIndustrial Clothings, Ltd.LYYClass I
K000139Midas Touch Blue Nitrile Examination Gloves-PowderedIndustrial Clothings, Ltd.LZAClass I
K000138Midas Touch Nitrile Examination Gloves-PowderfreeIndustrial Clothings, Ltd.LZAClass I
K991502Medtronic Ps Medical Polyurethane Shunt, Models 27521, 27116, 20022Medtronic PS MedicalJXGClass II
K002607Moss Miami 6.35Mm Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral ExtendersDepuyacromedKWPClass II
K002559El-Ana Profiles-2K1Theratest Laboratories, Inc.LJMClass II
K002517Uss VasSynthes (USA) Products LLCKWPClass II
K002044Magna Fortis Ophthalmoscope Diagnostic KitMagna Fortis CorporationHLJClass II
K001806Refractive Surgery BladesMillennium Biomedical, Inc.HNOClass I
K001800Accuwarm EMG Heat LampRjl Associates, LLCIKNClass II
K001642Insight Image Guided Surgical SystemSurgical Insights, Inc.HAWClass II
K002739Infusor Patient Control Module, 2Ml, Model 2C1067kBaxter Healthcare CorporationMEAClass II
K002722Digital Blood Pressure Monitor, Models Hd-503 and Hd-505Jawon Medical Co., Ltd.DXNClass II
K002511FetaltrolTrillium Diagnostics, LLCJPKClass II
K002448Latex Examination Gloves, Powdered, (Contains 100 Micrograms or Less of Total Water Extractable Protein per Gram).Oon Corp. ResourcesLYYClass I
K002416Golden-Rule Scaling CatheterMedical Device Technologies, Inc.DQOClass II
K002072Prolite Vl Pulsed Light SystemMedical Bio Care Sweden ABGEXClass II
K002040Fms SoloFuture Medical Systems, Inc.HRXClass II
K002032C02 Laser MultipulseAsclepion-Meditec AGGEXClass II
K001900Enzyme Immunoassay Anti-Ssdna Antibody TestHelix Diagnostics, Inc.LRMClass II
K001784Viridis LaserCosmos Medical TechnologyGEXClass II
K001461Tpn Nutrition Bag (Eva), Emptying Tube, Bag Syringe Fill SetBiometrix Ltd.KPEClass II
K002579Dermagrip Powderfree Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Microgram or Less)Wrp Specialty Products Sdn. Bhd.LYYClass I
K002477Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and CablesMasimo CorporationDQAClass II
K002470M2424a Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A TransducerAgilent Technologies, Inc.IYNClass II
K002465Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Respironics, Inc.BZDClass II
K002301Super 12Dental Alloy Products, Inc.EJHClass II
K002299Super 3Dental Alloy Products, Inc.EJHClass II
K002111Rubbercare Polymer-Coated Powdered Latex Examination Gloves/guardian Polymer-Coated Powdered Examination Gloves. ContaiPerusahaan Pelindung Getah (M) Sdn BhdLYYClass I
K002096Tampax Satin Tampons, Closed End Flushable Applicator; Tampax Tampons, Open End Flushable ApplicatorProcter & Gamble Co.HEBClass II
K001995Spiroxcard Diagnostic Spirometer and Pulse OximeterVectraCor, Inc.DQAClass II
K001951Primed Pleated Tie-Back, Procedure Mask Pm4-305, Primed Pleated Ear-Loop, Procedure Mask Pm4-306Primeline Medical Products, Inc.FXXClass II
K001766Olympus Xgif-N200h Gastrointestinal VideoscopeOlympus Optical Co., Ltd.FDSClass II
K001725Heartstream Xl Defibrillator/monitor, Model M4735aAgilent Technologies, Inc.MKJClass III
K000705Respironics Silhouette Nasal Mask, Models 1003224 and 1003223Respironics, Inc.BZDClass II
K000599Vitalograph Base StationVitalograph, Inc.BZGClass II
K002060Natural Ordinary Ribbed,dotted,and Contoured (Male Rubber Latex Condom, Lubricated W/silicone OilDongkuk Techco Rubber IndustriesHISClass II
K001872i.v. Set-Luer Lock with Latex Free Injection Site, Model B411Codan US Corp.FPAClass II
K001765Look Collagen Spacers, Model 1514BSurgical Specialties CorpKXKClass II
K001342P.o.p. Pain KitPost Operative Pain ManagementMEBClass II
K000997Zortran DetectorLucent Medical SystemsFOZClass II
K000830Cannulation Tourniquet Set, 2 Tube or 5 TubeCalifornia Medical Laboratories, Inc.DWFClass II
K000643Inplant Orthodontic Anchor SystemNobel Biocare Uas, Inc.DZEClass II
K994349Coaguchek S System, Model 2138280Roche Diagnostics GmbHJPAClass II
K002655Digital Blood Pressure Monitor, Model Md-550Meditec Co., Ltd.DXNClass II