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 3445 of 3526
510(k) clearances, page 3445 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K780846Draping Material, Colbalt 60 SterileKimberly-Clark CorporationKKXClass II
K780468Clinical Graphics AnalyzerNumonics Corp.DQKClass II
K780445Liquid Crystal Display Digital WatchHughes Aircraft Co.DRTClass II
K780393Biostator Glucose AnalyzerMiles Laboratories, Inc.CGAClass II
K7809305543 Independent Viewing SystemEmi Medical, Inc.JAKClass II
K780928Ct5137 High Resolution OptionEmi Medical, Inc.JAKClass II
K780922Um VII (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780921Mm-Ce Dm (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780920Mm-Ce 11 (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780919M25 Pp (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780918Primo Cedm (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780917Primo Ce (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780916780 Ue (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780915780 Se (Behind the Ear)Argosy Intl. (USA), Inc.ESDClass I
K780914Pm 25 Pp (Body Aid)Argosy Intl. (USA), Inc.ESDClass I
K780874Thymune-TBurroughs Wellcome Co.DDCClass II
K780873Thymune-MBurroughs Wellcome Co.DDCClass II
K780871Arterial Line KitArgon Medical Corp.GDYClass I
K780864Diamond StonesVenture Technology, Inc.DZPClass I
K780833Estic MicrofillDegussa Dental, Inc.EBFClass II
K780832Estilux MicrofillDegussa Dental, Inc.EBFClass II
K780830Isotonic Buffered SalineHarlecoGIFClass I
K780810Mla Electra 750 Coagulation TimerMedical Laboratory Automation Systems, Inc.JPAClass II
K780804Hygienic AnchoringsHygienic Dental Mfg., Co., theECIClass I
K780786Denture Reline MaterialDentsply Intl.EBIClass II
K780785Dilutor TransporterHyland Therapeutic Div., Travenol LaboratoriesJQWClass I
K780782M. 1336S Cathode-Ray Tube DisplayHewlett-Packard Co.DXJClass II
K780754Neonatal MonitorApplied Medical ResearchDXNClass II
K780716Technicon Bgii AnalyzerTechnicon Instruments Corp.CHLClass II
K780707T4-Ria KitClinical BioresearchCDXClass II
K780681Arteriovenous Blood Tubing SetsExtracorporeal Medical Specialities, Inc.FJKClass II
K780679B-Hcg-RiaNuclear Medical Systems, Inc.JHIClass II
K780653Extracorpeal Cardiotomy Blood FilterCobe Laboratories, Inc.JODClass II
K780569L-12, L-21, and L-22 ElectrodesCoratomic, Inc.DTBClass III
K780497Spheristem Total Hip ProsthesisAmerican Ortomed Corp.JDGClass II
K780391Podiatric MaterialCrown Delta Corp.MNEClass I
K780354Cryocyte PackTravenol Laboratories, S.A.KSRClass II
K780289Nerve ApproximaterEdward Weck, Inc.GDGClass I
K780892Fracture BracingHosmer Dorrance Corp.ITQClass I
K780891Post-Operative Hip OrthosisHosmer Dorrance Corp.ITSClass I
K780890Capp Terminal DeviceHosmer Dorrance Corp.IQXClass I
K780857Mixing Bowl & Spatula, DisposableHowmedica Corp.JDZClass I
K780847Ninhydrin Reagent KitBeckman Instruments, Inc.JMXClass I
K780827Uric Acid Rapid Stat KitPierce Chemical Co.KNKClass I
K780812Esophageal Motility System - Model 3330Honeywell, Inc.FFXClass II
K780802Armtrol and FermtrolBiotron, Ltd.JJWClass I
K780801Isozyme - Id Cpk MarkerDade, Baxter Travenol Diagnostics, Inc.JJTClass I
K780799Vitamin B12 RadioassayAmersham Corp.CDDClass II
K780798Gould-Statham Sp1405 Pressure MonitorGould, Inc.DSKClass II
K780797Transducer, Pressure, Option, H-P, P23idGould, Inc.DRSClass II