510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 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 2615 of 3530
510(k) clearances, page 2615 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K890689Adx Tm OpiatesAbbott MedicalDGJClass I
K890688Adx Tm PhencyclidineAbbott MedicalLCMUnclassified
K884522Model 5650 Optimate Personal ProgrammerTeletronics, Inc.KRGClass III
K884420Home Blood Pressure Kit, AneroidYamasu Co., Ltd.DXYClass III
K894894Anti-Sm MicroassayDiamedix Corp.LJMClass II
K894774Latex Patient Examination GlovesAmerican Rubber IndustriesLYYClass I
K894569Medpride Latex Examination GlovesTranscorpLYYClass I
K894220Houts Hysterectomy DrainFreudenberg Medical, LLCGBWClass I
K894197Latex Examination GlovesMedicare Industries, Inc.LYYClass I
K894074CO2 Surgical Laser SystemNiic U.S.A., Inc.GEXClass II
K894062Electronic Blood Pressure MonitorsHanson Scale Co.DXNClass II
K893492Latex Examination GlovesModern Rubber Industrial Co., Ltd.LYYClass I
K893346Latex Examination GlovesAvt Rubber Products, Ltd.LYYClass I
K892793Patient Examination Gloves (Vinyl)Zest Mark Industrial Co., Ltd.LYYClass I
K892791Patient Examination Gloves (Latex)Union Industrial Co., Ltd.IMMClass I
K891137Motility Orbital ImplantIntegrated Orbital Implants IncHPZClass II
K8948982Nd Skin Non-Stick Moist Burn PadsSpenco Medical Corp.FROUnclassified
K894891Irrigator StandCommercial Products & Engineering Co.HDCClass II
K894716Directable Coaxial Catheter SetCook Ob/GynGCJClass II
K894354Safeskin Powdred Hypoallergenic Steril Surg GlovesSafeskin Corp.KGOClass I
K894347Kaltocarb Wound DressingCalgon Vestal Div.FROUnclassified
K893688High Noble, Type III Dental Casting AlloyJelenko Co.EJTClass II
K893655Kobayashi Hook and Twist Kobayashi HookAmerican OrthodonticsEJFClass I
K892358Pegasys Nuclear Medicine Imaging ComputerPhilips North America LLCKPSClass II
K892177Patient Examination Gloves (Latex)Chem-Specialties Sdn BhdLYYClass I
K892174Latex Examination Gloves (Wintex)Windwell Agencies Sdn. Bhd.LYYClass I
K892171Disposable Latex Examination GlovesSoh King Neng & Sons Sdn BhdLYYClass I
K892170Patient Examination Gloves (Latex)Pattana Latex Co., Ltd.LYYClass I
K892164Patient Examination Gloves (Vinyl)King Handy Five Corp.LYZClass I
K892043Patient Examination Glove (Latex)Mwe Asia America Industries SdnLYYClass I
K891774Contimed II Biofeedback Dev Treat of Urin IncontiHollister, Inc.HIRClass II
K891773Microgyn II Elec Stim Device Treat of Urin IncontiHollister, Inc.KPIClass II
K894685Davis+geck Visaduct KitDavis & Geck, Inc.LROClass II
K893837Cvis Ultra-Scan One Imaging CatheterCardiovascular Imaging Systems, Inc.IYOClass II
K893822Honyee Vinyl Examination GlovesHonyee Enterprise Co.LYZClass I
K892319Latex Exam Gloves (Mfg. Kossan Latex Industries)Svenska Medita Ac.LYYClass I
K892318Vinyl Exam Gloves (Mfg. Universal Glove Corp.)Svenska Medita Ac.LYZClass I
K892317Vinyl Exam Gloves (Mfg. Tse Fong)Svenska Medita Ac.LYZClass I
K891833Glouch(tm) Patient Examination GlovesVadax, Inc.LZAClass I
K891268Bioshield and Universal Latex Exam GlovesDah Lee Rubber Industries (Thai), Ltd.LYYClass I
K891136Patient Examination Glove (Latex)Advance Rubber, Inc.LYYClass I
K890586Infrared DeluxeHealthteamILYClass II
K890585Infrared HexHealthteamILYClass II
K885018Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco HealthcGALClass II
K894793MonodexCenogenics Corp.KTNClass II
K894771Epilation NeedlePrecision Electrolysis Needles, Inc.KCWClass I
K894473Latex Examination GlovesProtech Industries Co., Ltd.LYYClass I
K894463Abuscreen Tri-Level Reference ControlsRoche Diagnostic Systems, Inc.LASClass I
K894456Latex Examination GlovesP T Perkasa Rubber IndustriesLYYClass I
K894438Micro-Aire Cutters for Midas-Rex InstrumentsMicro-Aire Surgical Instruments, Inc.GFFClass I