510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 1739 of 3531
510(k) clearances, page 1739 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K991759Maersk Medical Contour Infusion SetMaersk Medical A/SFPAClass II
K991704N/t Protein Control LcSiemens Healthcare Diagnostics Inc.JJYClass I
K991610Zeus Scientific Inc., Tpo Igg Elisa Test System.Zeus Scientific LLCDDCClass II
K991587Blom-Singer Indwelling 2000 Voice ProsthesisFreudenberg Medical, LLCEWLClass II
K991455Orthoslice Os1000 Series; Panoramic Orthoslice Os 1000: Os1000, Os1000e Panoramic and Cephalometric Orthoslice Os1000c,Trophy RadiologieEHDClass II
K991444Hermes Control Center, with Control of the Aesop 3000Hr (Hermes Ready).Computer Motion, Inc.GCJClass II
K991366Daum Mri/conventional Biopsy KitDaum Corp.KNWClass II
K991325Modification of Encore Linear Porous Coated HipEncore Orthopedics, Inc.LPHClass II
K991257Fuji Wavelet Compression or Ffcomp Irreversible CompressionFUJIFILM Healthcare Americas CorporationLLZClass II
K991168Arrow Fwd Power WheelchairInvacare GmbHITIClass II
K991081Frameless NeuromateIntegrated Surgical Systems, Inc.HAWClass II
K991053Astra Tech Implants - Dental System: New Fixtures (Micromacro)Astra Tech, Inc.DZEClass II
K991042Ash Advantage Peritoneal CatheterJanin Group, Inc.FJSClass II
K9907716F Hydrolyser Thrombectomy CatheterCordis US Corp.QEZClass II
K990484Independence 324Eagle Parts & Products, Inc.ITIClass II
K990122Independence 624Eagle Parts & Products, Inc.ITIClass II
K984508Surgical Contra-Angle Handpieces, Models 975 Ae,979 E/km, 985 Ae, 986 Ae, 988 E/km and Surgical Straight Handpieces ModW & H DentalWerk Buermoos GmbHDZAClass I
K984346Premier Type Specific Hsv-2 Igg Elisa TestMeridian Diagnostics, Inc.LGCClass II
K984343Premier Type Specific Hsv-1 Igg Elisa TestMeridian Diagnostics, Inc.MXJClass II
K991891Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc.GEXClass II
K991784Renew Lead ExtensionAbbott MedicalGZBClass II
K991775Modification to Computerized Catheterization Laboratory - Horizon 9000 WsMennen Medical, Inc.DXGClass II
K991690Latex Examination Gloves (Pre Powdered)Usg Healthguard Sdn BhdLYYClass I
K991689Latex Examination Gloves (Powder Free)Usg Healthguard Sdn BhdLYYClass I
K991653Invision-Plus Injection Port Connector SystemRyMed Technologies, LLCFPAClass II
K991035Quantec-E Irrigation SystemSybron Dental Specialties, Inc.EIAClass I
K991012Siemens Infinity EEG PodSiemens Medical Solutions USA, Inc.OLTClass II
K990688Mtm Bioscanner C Test StripsPolymer Technology SystemsCHHClass I
K990325Quikstrip Dipscan X Multidrug Screening DeviceSyntron Bioresearch, Inc.DKZClass II
K990020Te Me Na Loss of Resistance Syringe, 10CcTe ME NA S.A.R.L.FMFClass II
K984116Hepa-Care Air Cleaner American Air Filter Air Filtration System Models Hc800f, Hfs800f, Hc800c/ Hfs800c, Hc400c/hfs400cAbatement Technologies LimitedFRFClass II
K991859Dexide Bipolar Forceps II ** DeviceUnited States Surgical, A Division of Tyco HealthcGEIClass II
K991814Multachoice InstrumentsDexide, Inc.GEIClass II
K991752Brightway Brand Blue Color Latex Examination Glove, Powdered Containing 150 Mlgm or Less of Water Extractable Protein PeBrightsway Holdings Sdn BhdLYYClass I
K991750Brightway Brand Blue Color Latex Examination Glove, Powder Free Containing 50 Mlgm or Less of Water Extractable ProteinBrightsway Holdings Sdn BhdLYYClass I
K991749Laglove Brand Blue Color Latex Examination Glove, Powder Free Containing 50 Mlgm or Less of Water Extractable Protein PeLa Glove (M) Sdn. Bhd.LYYClass I
K991748Laglove Brand Blue Color Latex Examination Glove, Powdered Containing 150 Mlgm or Lessof Water Extractable Protein per GLa Glove (M) Sdn. Bhd.LYYClass I
K991746Royal Shield Powder-Free Pineapple Scented Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms orShield Gloves Manufacturer (M) Sdn BhdLYYClass I
K991745Royal Shield Non-Sterile Powder-Free, Green Latex Examination Gloves with a Protein Content Labeling Claim (50 MicrogramShield Gloves Manufacturer (M) Sdn BhdLYYClass I
K991744Smart Shield Non-Sterile Powder-Free, Blue Nitrile Examination Gloves with Bubblegum ScentShield Gloves Manufacturer (M) Sdn BhdLZAClass I
K991743Royal Shield Non-Sterile Bubble Gum Scented Powder-Free Latex Examination Glove with Protein Content Labeling Claim (5OShield Gloves Manufacturer (M) Sdn BhdLYYClass I
K991564JeltempJ.F. Jelenko & Co., Inc.EBGClass II
K991548Hal Scope Holder SystemNoved MedicalKKXClass II
K991313Accutred ShoeOrthopedic Technology Research, Inc.IRNClass II
K991304Health + Aid Premium Powder Free Nitrile Examination Gloves, BlueM.R.G. Industries Sdn. Bhd.LZAClass I
K991228Dci EndoscopeKarl Storz Endoscopy-America, Inc.GCJClass II
K991208Endoscopic Fiberoptic CableIsolux AmericaHBIClass II
K991190Deflectable Electrosurgical ProbesOratec Interventions, Inc.GEIClass II
K991184Hydrotone-Thermal Capsule SystemNats Corp.ILJClass II
K991171Dci EndoscopeKarl Storz Endoscopy-America, Inc.GCJClass II