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 3236 of 3528
510(k) clearances, page 3236 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K820494Sybron Bovie Csv Hand Contr. ElectrosurgSybron Corp.GEIClass II
K820431E.r.c.p. CannulasAmerican Endoscopy, Inc.ODDClass II
K820410Hemotec Hepcon/system Four & Four PHemotec, Inc.LOXClass II
K820301Plasma Pooler Heat SealerNorth American Biologicals, Inc.KSDClass I
K820254Gold Foil Erg ElectrodesCadwell Laboratories, Inc.HLZClass II
K820245Safe TdentProfessional Dental StudiosEBOClass II
K820232Transthoracic Temp. Pacemaker #100TpeTrans Pace, Inc.LDFClass II
K820185Reliner for Hearing Aid EarmoldsAid-To-Hearing Corp.ESDClass I
K813585Waters Ileostomy ValveWaters Instruments, Inc.KNTClass II
K813033Clay Adams Qbc Centrifugal HemotologyBD Becton Dickinson Vacutainer Systems PreanalyticGKGClass II
K820858EscortAmigo Sales, Inc.INMClass I
K820826Stax Finger SplintConco Medical Co.ILHClass I
K820810#4004 Triple Sugar Iron Agar Slants-TubeBiomedica, Inc.JSEClass I
K820809#2008 Simmons CitrateBiomedica, Inc.JSFClass I
K820807#2011 Strep Selective AgarBiomedica, Inc.JSJClass I
K820806#2004 Phenylethyl Alchol Agar W/sheep BlBiomedica, Inc.JSJClass I
K820805#2005 Sabouraud Dextrose Agar/#4002 SlaBiomedica, Inc.JSJClass I
K820804#2013 Cna 5% Sheep BloodBiomedica, Inc.JSJClass I
K820803#2003 Mycobiotic AgarBiomedica, Inc.JSJClass I
K820802#2009 Biggy AgarBiomedica, Inc.JSIClass I
K820801#2007 XldBiomedica, Inc.JSIClass I
K820800#2006 Salmonella Shigella AgarBiomedica, Inc.JSIClass I
K820799#2002 Mannitol Salt AgarBiomedica, Inc.JSJClass I
K820798#2001 HektoenBiomedica, Inc.JSIClass I
K820797#50001 Quade Diagnostic SystemBiomedica, Inc.JSIClass I
K820796#4001 Tubed Media - Fluid ThioglycollateBiomedica, Inc.JSCClass I
K820795#4006 Tsb-Tubed MediaBiomedica, Inc.JSCClass I
K820794#19012 Chocolate Mueller Hinton-150X15mmBiomedica, Inc.JTZClass II
K820793#1904L Mueller Hinton W/5% Sheep BloodBiomedica, Inc.JTZClass II
K820792#19041-150X15mm Mueller HintonBiomedica, Inc.JTZClass II
K820791#4005 Tsa Slant-Tubed MediaBiomedica, Inc.JSGClass I
K820787Helena Abnormal Hba2 Quik Column ControlHelena Laboratories, Corp.JCMClass II
K820786Aso Sure PlusAnalytical Products, Inc.GTQClass I
K820785Aso SureAnalytical Products, Inc.GTQClass I
K820773Emit-St Urine Cocaine Metabolite AssaySyva Co.DIDClass II
K820711Walk-a-CycleWalk-A-Cycle DivisionITJClass I
K820533B4182-1American Scientific ProductsGIEClass II
K820532Dispo Fibrin Pipet Tips B4182-2American Scientific ProductsGIEClass II
K820509Mem Vitamins (100XDutchland Laboratories, Inc.KITClass I
K820430Diathermic SnaresAmerican Endoscopy, Inc.KNSClass II
K820429Spiral Stone and Retrieval BasketsAmerican Endoscopy, Inc.OCZClass II
K820298Carcinoembryonic Antigen Control (4 LevVentrex Laboratories, Inc.DHXClass II
K820279Glyco-Gel Test KitPierce Chemical Co.LCPClass II
K812416Mark 500 SystemKallestad Laboratories, Inc.
K820788Clirans Priming SetTerumo Medical Corp.FPAClass II
K820750Enzymune-Test T4Icl ScientificKLIClass II
K820748Poli-Mak Model F-4 (FinalPm America, Inc.JJFClass I
K820740Mr1 Follitropin Ria KitMicroanalytic Research, Inc.CGJClass I
K820728Quantimune Estriol RiaBio-RadCGIClass I
K820628J-CatheterDna Medical, Inc.