510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3110 of 3528
510(k) clearances, page 3110 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K834344Med-Opedic Sleep SystemBemco Mattress Co.INXClass II
K834302Stayfree* Deodorant Maxi-PadsJohnson & Johnson Professionals, Inc.HHLClass II
K834169Op-Con Surgical Instrument #9Imm Enterprises, Ltd.BWBClass I
K833842Ria Coat DigoxinImmuno Assay Corp.DPOClass II
K833833Kodak Ektachem 700 AnalyzerEastman Kodak CompanyJJEClass I
K832989Breast Thermal Activity IndicatorBcsi Laboratories, Inc.KYAClass I
K832818Unscented Menstrual TamponBnt Co, Inc.HEBClass II
K832512Airway MasksArtec Environmental Monitoring DivisionCAEClass I
K832439Creatinine Reagent SetAmresco, Inc.CGXClass II
K834472Deseret Epidural CatheterParke-Davis Co.
K834463Laryngotracheal Topical Anes. AppliSheridan Catheter Corp.
K834456Helena Bio Strip ObHelena Laboratories, Corp.KHEClass II
K834412Preserv Pva Fixative 15Ml-Formalin PkPreventive Diagnostics Corp.KDTClass I
K834405Tec Traction MachineAkron Medical Corp.ITHClass II
K834400Flynn III-Child Bag-Mask Unit EtcO-Two Systems Intl., Inc.BTMClass II
K8343603-D Passive Mobilizer3-D Orthopedic, Inc.ISDClass II
K834327Cin AgarHardy MediaJSFClass I
K834325Inhibitory Mold AgarHardy MediaJSJClass I
K834323Potato Dextrose AgarHardy MediaJSGClass I
K834322Emmon 3 SabdexHardy MediaJSGClass I
K834321Thio W/supplementHardy MediaJSGClass I
K834320TcbsHardy MediaJSIClass I
K834319Bhi AgarHardy MediaJSGClass I
K834318Brucella W/h & KHardy MediaJSJClass I
K834317Selenite BrothHardy MediaJSJClass I
K834316Water W/tween 80Hardy MediaJSMClass I
K834315Sterile Saline 0.85%Hardy MediaJSMClass I
K834314Campy 5Hardy MediaJSJClass I
K834313Campy 3Hardy MediaJSJClass I
K834293Electronic Cell EnergizerElectronic Energy, Inc.LBGClass II
K834264Reverse-Flow SystemApplied Polytechnology, Inc.JTAClass I
K834151Conchatherm Lhf Humidifier HeaterRespiratory Care, Inc.BTTClass II
K834137Chiropractic Activator or Port. ChiroRhode Island Chiropractic Pain Clinic
K834107Angioplasty Inflation Device & CartrCordis US Corp.DXTClass II
K834103Table, Models 610,611 & 612Tri W-G, Inc.INQClass I
K834090Titertek Enterobac*Flow Laboratories, Inc.JSSClass I
K834020Peptic Digest AgarMicro Media LaboratoriesJSJClass I
K833950Total Protein Reagent Cs-724Fisher Scientific Company L.L.C.CEKClass II
K833931Urea Nitrogen-UVSeragen Diagnostics, Inc.CDQClass II
K833917Bac-T-ScreenMarion Laboratories, Inc.JTAClass I
K833898Tri-Level Bilirubin ControlsSandare Chemical Co., Inc.JJXClass I
K833881Acetabular Screw RingMecron Medical Products, Inc.JDIClass II
K833878Ventrezyme Digoxin Immunoassay DigoxVxr, Inc.KXTClass II
K833864Amylase Reagent Set-Modified CarawaySterling Biochemical, Inc.CJAClass II
K833854Lh RiaSyncor Intl. Corp.CEPClass I
K833852Fsh RiaSyncor Intl. Corp.CGJClass I
K833821Interad 520Interad Systems, Inc.IYXClass I
K833807Argyle Jet Tracheal TubeSherwood Medical Co.BTRClass II
K833804Shaban 9865 Il#78637 Junction BlocShaban Mfg. Co.JJFClass I
K833761Therapeutic Drug ControlIcl ScientificDKBClass II