510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 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 2475 of 3531
510(k) clearances, page 2475 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K905749Surgical Face MaskAnago, Inc.FXXClass II
K905436Nobelpharma Drilling Equipment Dec 500Nobelpharma USA, Inc.DZEClass II
K905424Ktp Disc KitLaserscopeGEXClass II
K905196LaparoscopeBaxter Healthcare CorporationHETClass II
K905183Neon Rubber SunglassesHa-Lo Advertising Specialties, Inc.HQZClass I
K905178Deluxe Sanitary PadAmerican Healthcare Corp.HHDClass I
K905091Various Male Quick Connects.Medical Fittings, Inc.BYXClass I
K902520Air Plus NebulizerDiamond Medical Equipment, Inc.BTIClass II
K902405Mallard Medical Model 2400 Anesthesia VentilatorMallinckrodt MedicalCBKClass II
K902347Compact Laser Imager, Model Cli-100Lumisys, Inc.LMCClass II
K905611Microrate Plus Intelligent PumpKendall Mcgaw Laboratories, Inc.FRNClass II
K905610Microrate Intelligent PumpKendall Mcgaw Laboratories, Inc.FRNClass II
K905530Puritan-Bennett Companion 500 Liquid Oxygen SystemMedtronic, Inc.BYTClass II
K905423Cordis Reflex Steerable GuidewireCordis US Corp.DQXClass II
K905408Nexus Acetabular CupDow Corning WrightJDIClass II
K904749Transkinetics Rado Freq Multi-Lead Tele Syst 7200Transtracheal SystemsDRQClass II
K904748Transkinetics Infrared Multi-Lead Tele Syst 7100Transtracheal SystemsDRGClass II
K904606Model 405Ivy Biomedical Systems, Inc.DPSClass II
K904507Pilling Brush ValvulotomePilling Co.DWQClass II
K904025Myotrack, Model Hh 515Myotrack Co.BXNClass II
K903524Horizon 2000 St Analysis OptionMennen Medical, Inc.DPSClass II
K902672Intermedics 430-07 Bipol Implant Endocard Pac LeadIntermedics, Inc.DTBClass III
K902564Needle, DialysisGainor Medical Europe, Ltd.FIEClass II
K9107633M Model 8245 Ite Hearing Aid3M CompanyESDClass I
K9107623M Model 8244 Ite Hearing Aid3M CompanyESDClass I
K9107613M Model 8243 Ite Hearing Aid3M CompanyESDClass I
K9107603M Model 8242 Ite Hearing Aid3M CompanyESDClass I
K9107593M Model 8241 Ite Hearing Aid3M CompanyESDClass I
K910744Philips Model S46-O Bte Hearing AidPhilips Hearing Instruments Co.ESDClass I
K910743Philips Model S46-Ol Bte Hearing AidPhilips Hearing Instruments Co.ESDClass I
K910705Active Model Ahx Helix Ite Hearing AidActive Electronics, Inc.ESDClass I
K910704Active Model Amc Mini Canal Ite Hearing AidActive Electronics, Inc.ESDClass I
K910703Active Model Aca Custom Canal Ite Hearing AidActive Electronics, Inc.ESDClass I
K910702Active Model Ahs Half Shell Ite Hearing AidActive Electronics, Inc.ESDClass I
K910701Active Model Alp Low Profile Ite Hearing AidActive Electronics, Inc.ESDClass I
K910700Active Model Ast Custom Ite Hearing AidActive Electronics, Inc.ESDClass I
K910579Ovarian Aspiration/irrigation NeedleMarlo Surgical TechnologyHETClass II
K910287Ott Cervical TenaculumMarlo Surgical TechnologyHDCClass II
K910018Post Auricular Hearing Aid Model Pico-Forte Pp-ScPhonak, Inc.ESDClass I
K910012Phonak Model Pico C-S-H-T, Bte Hearing AidPhonak, Inc.ESDClass I
K905706Gyn-1500 Hysteroscopic InufflatorCircon AcmiHIGClass II
K905705Lap 3501 High Flow InsufflatorCircon AcmiHIFClass II
K905535Aloka Ust-952Dp-5 Endovaginal TransducerGE Medical Systems Information Technologies, Inc.ITXClass II
K905474The Eyegaze SystemLc Technologies, Inc.ILQClass II
K905248Nova Microsonics Capricorn Digital Image SystemsAdvanced Technology Laboratories, Inc.DQKClass II
K904729Blom-Singer Shower GuardFreudenberg Medical, LLCEWLClass II
K910412Floxin Susceptibility Test DisksDifco Laboratories, Inc.JTNClass II
K910296Phosphorus (Inorganic) Test SystemBiochemical Trade, Inc.CEOClass I
K910222Cobas AlphaRoche Diagnostic Systems, Inc.JJGClass I
K910160Electrophoresis ControlSeradyn, Inc.JITClass II