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 2659 of 3530
510(k) clearances, page 2659 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K891322Disposable Latex Examination GlovesDuflex Products Sdn. Bhd.LYYClass I
K891307Patient Examination Gloves (Latex)Five Star Rubber ProductsLYYClass I
K891251Behind-the-Ear Hearing Aid Model 408 W-HSiemens Hearing Instruments, Inc.ESDClass I
K890971Patient Examination Glove, LatexYaung Jenn Co., Ltd.LYYClass I
K890798Revised Magnesium Test Item Number: Sr1019Em Diagnostic Systems, Inc.JGJClass I
K890528Roche Chloride ElectrodeRoche Diagnostic Systems, Inc.CGAClass II
K8904817610 Colorview Slave ScopeMarquette Electronics, Inc.DPSClass II
K890477The Spantron Frame FreezeSpantron, Inc.LMAClass II
K890453Reusable Mlyocardial Biopsy Forceps (BioptomesDlp, Inc.DWZClass II
K890340Intravascular Administration SetMulti-Med, Inc.FPAClass II
K890307Mityvac M Style Vacuum Extractor, DisposableNeward Enterprises, Inc.HDBClass II
K890301Shepard Intrauterine Insemination CatheterCook Ob/GynHDRClass II
K890123Clearfil Cr InlayKuraray Co.EBFClass II
K890083Gx-2000 Stationary X-Ray GeneratorGendex Corp.IZOClass I
K885253Acculevel One-Step Theophylline TestSyva Co.KLSClass II
K885177Physiogard Sm 785AdamDPSClass II
K884470Kimono Plus Others (Multiple) CondomsMayer LaboratoriesHISClass II
K884469Orion Plus W/nonoxynol-9 Others (Multiple) CondomsMayer LaboratoriesHISClass II
K884468Super Maxx Others (Multiple) CondomsMayer LaboratoriesHISClass II
K884308Mandible ManipulatorLeonard Medical, Inc.EKJClass I
K884292Stretcher TableFischer Imaging Corp.KXHClass I
K883917Natural Image Ultrasound Transmission CouplantSonomed Technology, Inc.IYOClass II
K882507Acs 0.015 & 0.018 Pressure Guide Wire W/micro.Advanced Cardiovascular Systems, Inc.DQXClass II
K881235Q-Plex 1Quinton, Inc.BZCClass II
K890724Mofification Bear Nvm-1 Neonatal Volume MonitorBear Medical Systems, Inc.BZKClass II
K890591Patient Examination GloveMarcon Rubber Industry Sdn. Bhd.LYYClass I
K885342Genny Denny IV ShieldMercury Enterprises, Inc.FMKClass II
K885242Microdelta IISiemens Gammasonics, Inc.IYXClass I
K891511Patient Examination Gloves (Latex)Oon Corp. ResourcesLYYClass I
K891425Patient Examination Gloves (Latex)Encore Technology, Inc.LYYClass I
K891402Uterine ClampsZinnanti Surgical Instruments, Inc.HGCClass I
K891399Corson Myoma Grasping ForcepsZinnanti Surgical Instruments, Inc.KNAClass II
K891397Greene-Armytage Hemostatic ForcepsZinnanti Surgical Instruments, Inc.KNAClass II
K891378Patient Examination Gloves (Latex)Sri Johani Sdn. Bhd.LYYClass I
K891369Comple-Safe Vinyl Examination GlovesUniversal Gloves Corp.LYZClass I
K891366Biosign Biological Indicator (Eight Month Exp.)Mdt Corp., Inc.FRCClass II
K891350Newport Cervical ManipulatorSimpson/Basye, Inc.HDCClass II
K891349Campion Cervical HookSimpson/Basye, Inc.HDCClass II
K891347Reid Endocervical SpreaderSimpson/Basye, Inc.HDCClass II
K891298Ambiderm(tm) Patient Examination Glove (Latex)Medi Tex, Inc.LYYClass I
K891291Patient Examination Gloves (Latex)Cp Products, Inc.LYYClass I
K891250Behind-the-Ear Hearing Aid Model 264 D-Pp-PcSiemens Hearing Instruments, Inc.ESDClass I
K891249Behind-the-Ear Hearing Aid Model 303 AspSiemens Hearing Instruments, Inc.ESDClass I
K891248Behind-the-Ear Hearing Aid Model 304 Pp-Agc-ISiemens Hearing Instruments, Inc.ESDClass I
K891247Behind-the-Ear Hearing Aid Model 404 Pp-PcSiemens Hearing Instruments, Inc.ESFClass II
K891011Resound Itc Hearing Enhancement Sys Hes2, W/remoteResound Corp.ESDClass I
K890985Vinyl Patient Examination GloveAm Gloves Co., Ltd.LYZClass I
K890880Aladan Sterile Latex Medical GloveAladan Corp.LYYClass I
K890816Patient Examination GlovesDan Co., Ltd.LYYClass I
K890667Rubber DamCost Rite Health Products, Inc.EIEClass I