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 3352 of 3526
510(k) clearances, page 3352 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K801023Asl Custom in-the-Ear Hearing Aid #LAmerican Sound LabsESDClass I
K801003Oticon Earette Hearing Aid #E17cfOticon, Inc.ESDClass I
K801002Oticon Earette Hearing Aid #E17 HcOticon, Inc.ESDClass I
K801001Ambulatory Monitor Am-1Burdick Corp.DSHClass II
K801000Large Screen Crt Display #1311BHewlett-Packard Co.DXJClass II
K800999Cam-10 Exsufflation Belt #11-001Lifecare Services, Inc.CBKClass II
K800998Atlas-S X-Ray System W/ketromat Gen.General X-Ray, Inc.
K800988Novametrix Tcomette #809 Trans. MonitorNovametrix Medical Systems, Inc.KLKClass II
K800981Chocolate Agar W/enrichmentsQuality Assurance Laboratory, Inc.JSGClass I
K800978Xylose Lysine Desoxycholate AgarQuality Assurance Laboratory, Inc.JSHClass I
K800939Computrim 900Amf, Inc.ISDClass II
K800891Resterilization of Implantable ElectrodeTelectronics, Inc.DTBClass III
K800869Model Pm-20(N)(r)co2 Patient Monitor/alaCavitron Corp.CCKClass II
K800867Dose Calibration Ref. Sources; Barium-13Amersham Corp.
K800866RoyalTrident Dental, Inc.BZRClass II
K800835Kandi-Nuclear Med. Data Acqu.&info.Krupp International, Inc.
K800801Analgesia Units, Oxygen & Nitrate DeviceSpica, Inc.BSZClass II
K800782Pace-Pulse/computracBib, Inc.KREClass II
K800760Bite Block SystemRadiation Products Design, Inc.
K800698Autofluor SystemCalifornia Immuno Diagnostic, Inc.JZTClass I
K800692Reagent for Determ. Potassium/in HumanDiagnostic Solutions, Inc.CEMClass II
K800691Reagent for Determ. Lactate/dehydrogenasDiagnostic Solutions, Inc.CFJClass II
K800690Reagent for Determ. Inorganic/phosphorusDiagnostic Solutions, Inc.CEOClass I
K800688Reagent for Determ. Glutamic-OxaloaceticDiagnostic Solutions, Inc.CITClass II
K800687Reagent for Determ. Glucose in H/serumDiagnostic Solutions, Inc.CGAClass II
K800686Reagent for Determ. Direct BilirubinDiagnostic Solutions, Inc.CIGClass II
K800685Reagent for Determ. Creatinine in H/seruDiagnostic Solutions, Inc.CGXClass II
K800684Reagent for Determ. Creatine PhosphokinaDiagnostic Solutions, Inc.JHYClass II
K800683Reagent for Determ. Chloride in Human/smDiagnostic Solutions, Inc.CHJClass II
K800682Reagents for Determ. Cholesterol/serumDiagnostic Solutions, Inc.CGOClass I
K800680Reagents for Determ. Calcium in HumanDiagnostic Solutions, Inc.CICClass II
K800679Reagents for Determ. Alkaline PhosphatasDiagnostic Solutions, Inc.CJEClass II
K800678Reagents for Determ. Albumin in HumanDiagnostic Solutions, Inc.CIXClass II
K800677Reagents for Determ. Serum Iron in HumanDiagnostic Solutions, Inc.JIYClass I
K800676Reagents for Determ. Sodium in Human SumDiagnostic Solutions, Inc.JGSClass II
K800675Reagents for Determ. Total BilirubinDiagnostic Solutions, Inc.CIGClass II
K800674Smac Replacement/total Protein Human SerDiagnostic Solutions, Inc.CEKClass II
K800673Smac Replacement Reagents/of Bun-SerumDiagnostic Solutions, Inc.CDWClass II
K800672Smac Replacement Reagents/determ-Uric-AcDiagnostic Solutions, Inc.CDHClass I
K800356Permanent Lead IntraducerDaig Corp.DYBClass II
K800355Lead, Sutureless MyocardialDaig Corp.DTBClass III
K800353Adapter KitDaig Corp.DTDClass II
K800352Pacemaker, ElectrodeDaig Corp.DTBClass III
K800351Pacemaker, Electrode, Perm. & Temp.Daig Corp.DTBClass III
K800350Endocard. Pacing Lead Std. Length Pl202Daig Corp.DTBClass III
K800349Endocard. Pacing Lead Long Length Pl200Diag Corp.DTBClass III
K800348Unipolar Lead Configuration ConductorDaig Corp.DTBClass III
K800347Perm. Inplant Endocard. Pac. LeadDaig Corp.DTBClass III
K801190Oxygen Tubing (Crush Resistant)/vinyl TpAirlife, Inc.BYXClass I
K801165Hyperstethoscope, Model Z 00Demonbinder ElectronicsDQDClass II