510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3006 of 3529
510(k) clearances, page 3006 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K850347Api Uniscept KbAnalytical Products, Inc.LTWClass II
K850208Flood Sources & Dose Calibrators W/various NuclidsSyncor Intl. Corp.IXDClass I
K850163Iridium 192 WiresSyncor Intl. Corp.IWAClass II
K850125Multi-Size Cassette HolderPhilips North America LLCIXYClass I
K845019Cell-Dyn 1000 Automated Hematology AnalyzerAbbott DiagnosticsGKLClass II
K845000Thrombinex Bovine ThrombinBio/Data Corp.GJAClass II
K844375Eigen Floro-Stor Fs-100Eigen VideoJAAClass II
K850985Flexus 2 CO2 Surgical Laser SystemIntl. Solarium Manufacturer, Inc.GEXClass II
K850963Dupont Prep Type Si Extraciton CartridgeE.I. Dupont de Nemours & Co., Inc.DJYClass I
K850922Mem D-Val Modif. M7395, W/ebss, L-Glutamine, D-ValSigma Chemical Co.KITClass I
K850921Mem, M7270, W/ebss, L-Glutamine & W/o L-Leucine -Sigma Chemical Co.KITClass I
K850916SprayfixSurgipath Medical Industries, Inc.PPMClass I
K850908Titertek Microittration Equip. Handiwash 110 12ChaFlow Laboratories, Inc.JTCClass I
K850891Dulbecco's Modified Eagle's Medium D7777, W/l-GlutSigma Chemical Co.KITClass I
K850890Mccoy's 5A M9270 W/l-Glutamine & W/o Phenol Red &Sigma Chemical Co.KITClass I
K850808Cobas Fp Reagents for QuinidineRoche Diagnostic Systems, Inc.LBZClass II
K850806Corning Blood Collection Capillary TubesCorning Medical & ScientificGIOClass I
K850790Diaflex Occlusion Balloon CatheterAmerican Edwards LaboratoriesKODClass II
K850784Bronchitrac LAckrad LaboratoriesBSYClass I
K850763Earette Hearing Aid Oticon E32uOticon, Inc.ESDClass I
K850762Earette Hearing Aid Oticon Model E32sOticon, Inc.ESDClass I
K850724Culture Media Nonselective & NondifferentialRapid City Regional Hospital, Inc.KZIClass I
K850703Saf T Flo Ventilator TubingBivona Medical TechnologiesBZOClass I
K850675Curay Join Dent Dentin PrimerScientific Pharmaceuticals, Inc.EBDClass II
K850597Micro-Aire High Speed Oral Surgerg DrillMicro-Aire Surgical Instruments, Inc.EFBClass I
K850461Automatic Impedance Meter Ta-7ATeledyne Avionics Div. of TeledyneETYClass II
K850344Am-40 Power Optic Air Motor Power Optic Contra AngMidwestEGSClass I
K850338Emergency Room PackMarwood Medical, Inc.
K850263Pediatric Anesthesia Mask W/pacifier/ring AssemblyPlasmedics, Inc.BSJClass I
K850243Hearing Aid 365Telex Communications, Inc.ESDClass I
K850190Star 66F-Agc-I Hearing AidRobert Bosch Corp.ESDClass I
K850189Bosch Star 66Pp-S Hearing AidRobert Bosch Corp.ESDClass I
K850187Bosch Starr 66Pp -Hearing AidsRobert Bosch Corp.ESDClass I
K850185Body Hearing Aids Mt 80 SpRobert Bosch Corp.ESDClass I
K844867Duallor R SolderDegussa Dental, Inc.EJTClass II
K844858Storz/urban Surgical Microscope SystemStorz Instrument Co.EPTClass I
K844846Espe Ketac-Cem RadiopaqueEspe GmbH (US)EMAClass II
K844729Resuscitator, Pulmonary, ManualLife Design Systems, Inc.BTMClass II
K844662Kerr Herculite Dental Composite Restorative MateriKerr Corporation (Danbury)EBFClass II
K844653Limi AlloyG-C Intl. Corp.EJJClass II
K842352Pressure Monitoring KitUtah Medical Products, IncDRSClass II
K841788Utah Disposable Pressure TransducerUtah Medical Products, IncDRSClass II
K840837Tbi TrainerManicoFEJClass I
K850807Cobas Fp Reagents for CarbamazepineRoche Diagnostic Systems, Inc.KLTClass II
K850723Sabouraud's Dextrose Agar, Bordet Gengou Agar, MycRapid City Regional Hospital, Inc.JSIClass I
K850722Martin Lewis AgarRapid City Regional Hospital, Inc.JTYClass II
K850721Kliger's Iron Agar, Sim Media, Mrvp Medium, Bile ERapid City Regional Hospital, Inc.JSHClass I
K850720Eosin Methylene Blue Agar, Ss Agar, Xld Agar 6.5%Rapid City Regional Hospital, Inc.JSIClass I
K850719Dnase Test Media, Christensen's Urea AgarRapid City Regional Hospital, Inc.JSHClass I
K850717Amies Transport MediaRapid City Regional Hospital, Inc.JSMClass I