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 2657 of 3530
510(k) clearances, page 2657 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K891068Ventrex Coated Tube T3 UptakeVentrex Laboratories, Inc.KHQClass II
K890990Extend Intended Use for Enzyme Rinse ConcentrateHichem DiagnosticsCHHClass I
K890721Shape-Actio Metal Toxicology ControlActio, Inc.DIEClass I
K890707Phrenic Nerve Pad & Nerve Pad W/1/4 PercardialDlp, Inc.DWSClass I
K890698Abbott Alt-Activated (Liquid, List #01A55)Abbott MedicalCKAClass I
K890695Hi-Rider WheelchairRetec USA, Inc.IPLClass II
K890584Hi Chem Calcium Reagent #88808Hichem DiagnosticsCJYClass II
K890514Pre-Moistened Cleansing PadBausch & Lomb IncorporatedLKBUnclassified
K890129Pleur-Evac(r) a-8020--Infant Chest Drainage SystemDeknatel, Inc.GCXClass II
K885294Borrelia Burgdorferi Igm Antibody Test SystemMedical Diagnostic Technologies, Inc.LSRClass II
K885293Borrelia Burgdorferi Igg Antibody Test SystemMedical Diagnostic Technologies, Inc.LSRClass II
K885290Borrelia Burgdorferi Polyvalent Igg/igm AntibodyMedical Diagnostic Technologies, Inc.LSRClass II
K884524Hts 220 Cardiac MonitorLife Sensing Instrument Company, Inc.DSIClass II
K884249Modified Ddi Serocard Toxoplasma Igg Test KitDisease Detection International, Inc.LGDClass II
K884248Modified Ddi Serocard Cmv Igg Test KitDisease Detection International, Inc.LFZClass II
K884247Modified Ddi Serocard Rubella Igg Test KitDisease Detection International, Inc.LFXClass II
K884246Modified Ddi Serocard Herpes Igg Test KitDisease Detection International, Inc.LGCClass II
K874390Crack-It Cannabinoid ScreenSakers, Inc.LDJClass II
K891764Fc-101 Femoral Catheter Guide WireAkcess Medical Products, Inc.LFKClass II
K891763Fc-100 Femoral CatheterAkcess Medical Products, Inc.LFKClass II
K891754Dc-4 Shunt Infusion TAkcess Medical Products, Inc.FKBClass II
K891752Da-46 Fluid BarrierAkcess Medical Products, Inc.FIBClass II
K891743Patient Examination Gloves (Latex)Dispotex Industries Sdn. Bhd.LYYClass I
K891648Gold Class, Grandtex, Latex Examination GlovesHarry Panzer Intl. Corp.LYYClass I
K891592Orthodontic Arch and Surgical HooksAmerican OrthodonticsEJFClass I
K891526M-56 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891515C-52 Gold Base Dental AlloyMacdonald Metals and CeramicsEJTClass II
K891409Precept Micro-Gard Laser MaskMars White KnightFXXClass II
K891406Balloon (Nephrostomy Tract) Dilation Catheter SetCook IncorporatedLJEUnclassified
K891159Sodium Bicarbonate, U.s.p.Williams Medical Co.KPOClass II
K891090SpecboardMacbrud Corp. Medical Div.IZHClass II
K890941Modified Suture Disp. Endoscopic Surgical Clip AppUnited States Surgical, A Division of Tyco HealthcGDOClass I
K890672Absorbent Gauze RollSmith & Nephew United, Inc.NABClass I
K890463Ultrasound Procedure Tray Amnicentesis TrayCritical Specialties, Inc.HIOClass I
K890293Aide-a-Patient (Nursing Home Bed)Morton Metalcraft Co.FNLClass II
K890197Omnifit Constrained Acetabular Bearing InsertOsteonics Corp.KWZClass II
K884027Perfecta Ii/non-Coated Total Hip SystemOrthomet, Inc.JDIClass II
K891609Carrette 3 Wheeled Motorized CartEverest & Jennings, Inc.INIClass II
K891508Patient Examination Gloves (Latex)Safeway Products, Inc.LYYClass I
K891507Patient Examination Gloves (Latex)Purna Bina Sdn BhdLYYClass I
K891461Surgilase Yag 100 Surgical Nd:yag Laser/gen SurgSurgilase, Inc.GEXClass II
K891401Hemostatic Forceps Bruns.,gemini,spencer-Well,kantZinnanti Surgical Instruments, Inc.GENClass I
K891400Micro Cautery NeedlesZinnanti Surgical Instruments, Inc.JOSClass II
K891260Patient Examination Gloves (Latex)The Glove Outlet, Inc.LYYClass I
K891203Scissors: Thorek, Jorgensen, FinochiettoZinnanti Surgical Instruments, Inc.LRWClass I
K891200Ribbon Type Scissors: Tenotomy,iris,eye,strabismusZinnanti Surgical Instruments, Inc.LRWClass I
K891192Medi-Trace Thermal Video Film PaperGraphic Controls Corp.LMDClass I
K891151Cool 'N Heat MachineKCI USA, Inc.ILOClass II
K891031Kirschner RetractorZinnanti Surgical Instruments, Inc.GADClass I
K891017Patient Examination GloveParamount Products, Inc.LYYClass I