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 3193 of 3528
510(k) clearances, page 3193 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K823026380 Piggyback ControllerImed Corp.LDRClass II
K822885Halo Traction Cervical ImmobilizationMizuho Orthopedic Systems IncHAXClass II
K822809Azlocillin 75 Mcg Susceptibility DiscGeneral DiagnosticsJTNClass II
K822252ENT Treatment UnitsKelleher Corp.ETFClass I
K823087Boehringer Manneheim Diag. Acid PhosphaBoehringer Mannheim Corp.CKBClass II
K823270Heavy-Duty i.v. StandE.F. Brewer Co.FOXClass I
K823134Air Flow IIHealthco, Inc.ELCClass II
K823133Air Flow IHealthco, Inc.EIAClass I
K823121Ritc-Anti Human Iga, Igg, Kappa, LambdaAmico Lab, Inc.DFHClass II
K823103Dialysate Additives-Powder/liquidDi-Chem, Inc.KPOClass II
K823066Desert Insyte-a Hyperthermia Sensor AccParke-Davis Co.FLLClass II
K823002Dendrite Vm-Transcutaneous Elec. NerveTri W-G, Inc.GZJClass II
K822997Strep Selective AgarGranite Diagnostics, Inc.JSIClass I
K822929Veril/ppr Personal Pain Reliever #800VeriteGZJClass II
K822829Rotary Vascular KnifeMedco Products, Co., Inc.DWSClass I
K822765Sigmoidoscope, FlexibleHarvard LaboratoriesFAMClass II
K822679Fitc Antisera to Human C3Amico Lab, Inc.DFHClass II
K822678Fitc Antisera to Human GobulinAmico Lab, Inc.DFHClass II
K822677Fitc Antisera to Human IgmAmico Lab, Inc.DFHClass II
K822676Fitc Antisera to Human IggAmico Lab, Inc.DFHClass II
K822675Fitc Antisera to Human IgaAmico Lab, Inc.DFHClass II
K822674Fitc Antisera to Human LambdaAmico Lab, Inc.DFHClass II
K822673Fitc Antisera to Human KappaAmico Lab, Inc.DFHClass II
K822671Antiserum to Human GobulinAmico Lab, Inc.DFHClass II
K822670Antiserum to Human IgmAmico Lab, Inc.DFHClass II
K822669Antiserum to Human IggAmico Lab, Inc.DFHClass II
K822668Antiserum to Human IgaAmico Lab, Inc.DFHClass II
K822667Antiserum to Human LambdaAmico Lab, Inc.DFHClass II
K822666Antiserum to Human KappaAmico Lab, Inc.DFHClass II
K822087Dia ScopeExitec, Inc.KNTClass II
K823247U-Way QuickollarEms Industries, Inc.IQKClass I
K823245Thermax; Thermax SystemAmerican Thermometer Company, Inc.KYAClass I
K823218Disposable Dispense ManifoldDynatech Laboratories, Inc.JTCClass I
K823198Rapid Presumptive Ident. Gpa StrepMicrochemical Specialities, Co.JTOClass I
K823179Chlamydia Transettee 1 & 3Spectrum Co.JSMClass I
K823175Sidewinder Omni Wheelchair Direct/powerKCI USA, Inc.ITIClass II
K823174Microsurgical InstrumentsConcept, Inc.HNRClass I
K823165Wrist Spling & Forearm SplintWarm & Form, Orthopedic MaterialsILHClass I
K823164Abdominal BinderWarm & Form, Orthopedic MaterialsKTDClass I
K823126Model Sa-1 Stethoscope Audio AmplifierElectromedics, Inc.BZWClass I
K823117Hitch HikerAmigo Sales, Inc.ITIClass II
K823113Brace-Up All Purpose Wrist BandArco Matic, Inc.IQIClass I
K823110Qap Microcomputer SystemAmerican DadeJQPClass I
K823107Quantimetric 2 Ceruloplasmin AssayKallestad Laboratories, Inc.DDBClass II
K823106Rermco Test Chloride ReagentFermco Biochemics, Inc.JFSClass II
K823093Channel BackJ.G. Shuman Assoc.
K823082Travasorb Nasogastric NasointestinalTravenol Laboratories, S.A.KNTClass II
K823050Cin Agar MediumGibco Laboratories Life Technologies, Inc.JSJClass I
K823025Km - Kal 2Kmn Products, Inc.JITClass II
K823024Km - Kal 1Kmn Products, Inc.JITClass II