510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3492 of 3526
510(k) clearances, page 3492 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K770689Hearing Aid Model A8h and A8tWidex Hearing Aid Co., Inc.ESDClass I
K770688Hearing Aid Model F8h Anl F8tWidex Hearing Aid Co., Inc.ESDClass I
K770667Chromascan TmSterndent Corp.KZNClass II
K770331Dialysis, Jet SystemJanneck Ent. of TexasEKPClass I
K770593Corrugated Tubing #770 & 771Surgicot, Inc.BZOClass I
K770581Corrugated Tubing, 770 & 771C.D. & F. Corp.BZOClass I
K770086SanarHealth Improvement Assoc.IMBClass II
K770012Q-Pak Chemistry Radioreceptor Control CHyland Therapeutic Div., Travenol LaboratoriesJIXClass II
K770011Q-Pak Chemistry Radioreceptor Control BHyland Therapeutic Div., Travenol LaboratoriesJIXClass II
K770010Q-Pak Chemistry Radioreceptor Control aHyland Therapeutic Div., Travenol LaboratoriesJIXClass II
K770673Collector, Sani-Catch, No. 1014Concord Laboratories, Inc.KNXClass II
K770672Collector, Sani-Catch, No. 1010Concord Laboratories, Inc.KNXClass II
K770665Valve, Pressure, DemandMcgaw Respiratory TherapyCBDClass II
K770662Viewer, Fluorometic, Model 721Corning Medical & ScientificJZTClass I
K770650Pre-Duced Culture MediaGibco Laboratories Life Technologies, Inc.JSLClass I
K770642Syringe, Endodontic W/notched Tip NeedleNational Patent Development Corp.EICClass I
K770636Table, Exam & ManupulationI E IndustriesINTClass I
K770602Valve, Ascites, LaveenBD Becton Dickinson Vacutainer Systems PreanalyticKPMClass II
K770578Parallel Plate DialyzerCobe Laboratories, Inc.FJGClass II
K770572Dp-5000 Data Reduction SystemBeckman Instruments, Inc.JJJClass I
K770548Immunoplate III Radio ImmunodiffusionHyland Therapeutic Div., Travenol LaboratoriesJZQClass I
K770544Scissors, Bandage, 15,18,20Cm., AngularSea-Pac Trading Corp.FZTClass I
K770543Scissors, Surgical, Angular, 14 Cm.Sea-Pac Trading Corp.FZTClass I
K770542Scissors, Mayo _Tyle, 14,16,18,20,22 Cm.Sea-Pac Trading Corp.FZTClass I
K770541Scissors, Surgical, 12.5,14,16 & 18 Cm.Sea-Pac Trading Corp.FZTClass I
K770540Forceps, Mosquito Style, 12.5 Cm.Sea-Pac Trading Corp.GENClass I
K770539Forceps, Haem, Deep Operation, 20&22 Cm.Sea-Pac Trading Corp.GENClass I
K770538Forceps, Haemostatic, 14 16,&18 Cm. LongSea-Pac Trading Corp.GENClass I
K770535C-Dak 3500Cordis US Corp.FIGClass II
K770494Blood Gas Analyzer-Calibration GasGardner CryogenicsJIXClass II
K770482Catheter, Single Puncture YMdl Medical Device Laboratories, Inc.KOCClass II
K770439Stoma Bag W/skin Barrier Seal RingHollister, Inc.EXBClass I
K770433Q-TipsChesebrough-Pond'S U.S.A. Co.KXFClass I
K770425Needles, Sterile, AirwayPfizer PharmaceuticalsFMIClass II
K770417AnimatorKdk Medical ProductsITJClass I
K770414Probe Retractor, Part #S-2L8-6Acme United Corp.GADClass I
K770409Steri-Stor TmResearch Surgical SystemsFRGClass II
K770380Chemistry Control-Low & High Tqc TmTechnicon Instruments Corp.JJYClass I
K770364Aca Lipase Analytical Test PackE.I. Dupont de Nemours & Co., Inc.CETClass I
K770347Meter, Ph, Digital, Model 3560Beckman Instruments, Inc.JQYClass I
K770280Cord, Electrosurgical-Sterile & Dispos.V. Mueller O.V. Baxter Healthcare Corp.KNSClass II
K770215Activator LightGte Sylvania, Inc.EBZClass II
K770651Retractors & Hooks, AbramsonEdward Weck, Inc.GADClass I
K770644Ultrasound B-Scanning SystemUnirad Corp.HEMClass II
K770590Surgi-KitEthox Corp.KCTClass II
K770568Surgical Illuminator (Sil)Fiber Optics Engineering, Inc.FTDClass II
K770567Light, Examination, Medical (Mel)Fiber Optics Engineering, Inc.FTDClass II
K770634Adapter Be 105-101 & 125-101Instrumentation Industries, IncorporatedBZAClass I
K770632Gas Collhctor Be 155(155-2-3,154-4)Instrumentation Industries, IncorporatedKGKClass I
K770623Conductive Cream-500Graphic Controls Corp.GYBClass II