510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 3307 of 3528
510(k) clearances, page 3307 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K803179Disposable Electrode for EKGMidwest MonitoringDRXClass II
K802924Kontron Percutaeous Double-LumenAvco Medical ProductsDSPClass II
K802900Heart SentinelTotemite Medical ElectronicsDSIClass II
K801903Series 4000 Stress & Exercise SystemInstruments for Cardiac ResearchDSIClass II
K810247Mbi-4Bloomex International, Inc.IPFClass II
K810626Ela Medical Pacing Lead Model PMA 860Ela Medical, Inc.
K810543Neo-Wave SystemGaymar Industries, Inc.INXClass II
K810511Beckman Du-8 SpectrophotometerBeckman Instruments, Inc.JJQClass I
K810509Digital Dispensing PumpDynatech Corp.JQWClass I
K810468Emit-St Serum ControlsSyva Co.DIFClass I
K810467Emit-St Serum Ethyl Alcohol AssaySyva Co.DMTClass II
K810466Ethyl Alcohol Serum CalibratorSyva Co.DNNClass II
K810465Emit-St Ethyl Alcohol Serum ControlsSyva Co.DKCClass I
K810464Emit-St Serum CalbratorSyva Co.DKBClass II
K810463Emit-St Serum Benzodiazepine AssaySyva Co.JXMClass II
K810394Pre-Vap CapsSherman BoosalisJJCClass I
K810323Acrytol, Mounting MediumSurgipathKEPClass I
K810268NormlceraMedical Specialties LaboratoriesKISClass I
K810230Condylar Knee W/metal Encapsulated TibHexcel MedicalHRYClass II
K810214Dac-Cel DiagnatalBurroughs Wellcome Co.JHIClass II
K803314Skin Beauty Cleanser & TonerDynex International, Ltd.IPFClass II
K803095Copper Sulfate Solution Sp. Gr.1.055Accra Laboratories, Inc.KSLClass I
K803094Copper Sulfate Solution Sp. Gr.1.053Accra Laboratories, Inc.KLSClass II
K810416Sarns Mini-Sucker3M Health Care, SarnsGCYClass I
K810412Usci Cardiovascular CatheterC.R. Bard IncDQOClass II
K810410Sterile PackagingTelectronics, Inc.DXYClass III
K810395Pre-Bypass FilterTexas Medical Products, Inc.KRJClass II
K810376Meadox Szilagyi GraftMeadox Medicals, Div. Boston Scientific Corp.DSYClass II
K810366Fancy Tan SunbedFancy Tan, Inc.LEJClass II
K810258Proximal Fermoral Hip ReplacementZimmer GmbHJDOClass II
K810163Am 420 MicroprocessorHoneywell, Inc.DXGClass II
K810076Pheresis Needle AssemblyHaemonetics CorporationGAAClass I
K810073Mark 500 SystemAdvanced Technology Laboratories, Inc.IYOClass II
K802890Cps-1000Gics PharmaceuticalsDTNClass II
K810514Sandare Nitroprusside Test ProcedureSandare Chemical Co., Inc.JLCClass I
K810499Percutaneous Gastrointestinal TubeHealth Development Corp.KNTClass II
K810457Grooming AdaptorsFred Sammons, Inc.ILWClass I
K810456Hygiene AdaptorsFred Sammons, Inc.ILSClass I
K810455Eating UtensilsFred Sammons, Inc.ILCClass I
K810454Homemaking UtensilsFred Sammons, Inc.IKWClass I
K810453Dressing AdaptorsFred Sammons, Inc.ILDClass I
K810452Non-Powered Communication SystemsFred Sammons, Inc.ILPClass I
K810451Reuseable Hot & Cold PacksFred Sammons, Inc.IMEClass I
K810450Truncal OrthosisFred Sammons, Inc.IQEClass I
K810449Transfer AidsFred Sammons, Inc.IKXClass I
K810448Wheelchair AccessoriesFred Sammons, Inc.KNOClass I
K810447Magic Cushion MassagerFred Sammons, Inc.ISAClass I
K810446VibratorFred Sammons, Inc.IROClass I
K810445Mechanical TableFred Sammons, Inc.INWClass I
K810444Non-Measuring ExercisersFred Sammons, Inc.IONClass I