510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2857 of 3529
510(k) clearances, page 2857 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K863915Shape-Actio Metal Toxicology ControlShape Products Co.DIEClass I
K863901Iq Urea NitrogenBD Becton Dickinson Vacutainer Systems PreanalyticJGZClass II
K863889Urea Nitrogen TestU. S. Diagnostics, Inc.CDLClass II
K863880Blood Gases/ Po2, Pco2 and Blood Ph Analysis Prod.D.R.G. Scientific IndustriesCHLClass II
K863849Liqui-Sera Combo Ligand/tdm ControlsBiodiagnostic IntlJJYClass I
K863825Co-Oximeter SolutionsD.R.G. Scientific IndustriesJKSClass I
K863751Multi-Analyte Lin-TrolSigma Diagnostics, Inc.JJYClass I
K863742Flexmedics Nitinol Arch WireFlexmedicsDZCClass I
K863583Change in Fiberlase 100 Nd:yag Medical LaserLaser MediaLNKClass II
K863558Uresil Carotid ShuntUresil, LLCDWFClass II
K863361Model 8900 Nd:yag Laser, Treatment of MenorrhagiaCooper Lasersonics, Inc.HHRClass II
K8633387.5 Mhz Linear Small Parts ProbeSiemens Medical Solutions USA, Inc.IYOClass II
K863109FerrofastJ. D. Assoc.JIYClass I
K863102Glucometer-EJ. D. Assoc.CGAClass II
K863056Bilirubin TotalJ. D. Assoc.CIGClass II
K862958Amr Research TonometerAssociated Medical RepresentativesLCHClass I
K862903Middle Ear Viewer and Fluid CollectorSteven K. JuhnJZFClass I
K862478Hayes Vaginal ShieldFranklin Medical USA, Inc.HDFClass I
K864011Exu-Dry Burn/trauma Dressing, Various SizesFraass Survival Systems, Inc.NADClass I
K864399Fisher Price SunjammersFisher PriceHQYClass I
K864084Lyofoam C Odor-Absorbing DressingAcme United Corp.FROUnclassified
K863861Tandem-M Immunoenzymetric Assay for Hum/chor/gonaHybritech, Inc.JHIClass II
K863860Tandem-M Immunoenzymetric Assay for ProlactinHybritech, Inc.CFTClass I
K863859Tandem-M Immunoenzymetric Assay for Thyr/stim/hormHybritech, Inc.JLWClass II
K863838Crest Cervical TractionCentral Equipment Sales, Inc.
K863784Nellcor N-200 (Pulse Oximeter)Nellcor, Inc.DQAClass II
K863534Life-Watch Monitor Lt-8Elekta LimitedDRTClass II
K863366Pregelled Dispos. Elect., Silver-Silver ChlorideLabeltape Meditect, Inc.DRXClass II
K864287Model 430-05 Polyflex Implantable Pacing LeadIntermedics, Inc.DTBClass III
K864163Hall Dunbar Drill Guide SystemHall Surgical, Division of Zimmer, Inc.HRXClass II
K864155Modification of Carpentier-Edwards BioprosthesisAmerican Edwards LaboratoriesDTJClass I
K864002Model 431-06 Polyflex Implantable Pacing LeadIntermedics, Inc.DTBClass III
K863845Em III Disposable ElectrodeElectromed Intl., Ltd.DRXClass II
K863724Model 6000 Ambulatory ECG Analysis SystemOxford Medilog, Inc.DSIClass II
K863596Chin-Fogarty Inflation DeviceAmerican Edwards LaboratoriesDXTClass II
K863427Clampease FaFreund Medical ProductsDXCClass II
K863138Terumo Radifocus Guide WireTerumo Medical Corp.DQXClass II
K863030630C ElectrocardiographQuinton, Inc.DPSClass II
K862316Case 12Marquette Electronics, Inc.DSIClass II
K861179Candela Model Spt-1, Pulsed Dye LaserCandela CorporationGEXClass II
K860858Olympus Pf-18 & Pf-25 Ultrathin AngioscopeOlympus Corp.LYKClass II
K864384Luxtec Retractors, Luxtec Specialty RetractorsLuxtec Corp.GADClass I
K864380Lutex Headlight SystemsLuxtec Corp.FSTClass II
K864338Secondary Set LockTravenol Laboratories, S.A.FPAClass II
K864325Dr7700 Operating TableKoken Mfg Company, Inc.FQOClass I
K864314Eftekhar Rechannelization Drill GuideThe Anspach Effort, Inc.HSZClass I
K864295Dr.500o Operating TableKoken Mfg Company, Inc.FQOClass I
K864195Surface Skin Temp Probe W/thermocouple Type TRespiratory Support Products, Inc.FLLClass II
K864106Sr-Model 230 (Modification)Hirata Sangyo Co. USA, Inc.FRNClass II
K864059Dental Prophy Cups (Various Types)Mission White Dental, Inc.EHKClass I