510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 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 2433 of 3531
510(k) clearances, page 2433 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K910889Abc Laparoscopic HandprobeBirtcher Medical Systems, Inc.GEIClass II
K910871Edentec Digital Charter Model 3710Edentec Corp.DSFClass I
K910870Edentec Model 3711 Digital RecorderEdentec Corp.DRTClass II
K910822Bard Peripheral Balloon Dilatation CatheterC.R. Bard IncLITClass II
K904873Sterile Surgical PackAngelica Healthcare ServicesKKXClass II
K904435Ventrofil Tension Relief Suture SetAesculap IncKGSClass I
K903774Lp-PlusFidelity Medical, Inc.DPSClass II
K913522Solitens ModifiedInnovative Designer Products, Inc.GZJClass II
K913301Mcs 50Mo X-Ray Tube Insert/mxs 50Mo Tube Hou AssemComet North America, Inc.ITYClass I
K913046Frames (Eye Glasses)Jiuh Chyi Ent. Co., Ltd.HQZClass I
K912860Intravascular Administration SetsPacific Device, Inc.FPAClass II
K912836Cannula and TrocarOceanside BiomedicsGCJClass II
K912739Site 90 Tip, I/a Handpiece .3Mm Side Open/opth UseSite Microsurgical Systems, Inc.HQCClass II
K912450Tracets Sme 5000Lectec Corp.DRXClass II
K912449Micro-X 15 HFFischer Imaging Corp.IZOClass I
K912448CspFischer Imaging Corp.OWBClass II
K912439Tandem-E Tsh Calibration Verification Control SetHybritech, Inc.JJXClass I
K912435Dental Connector Precision AttachmentMetalor Dental USA Corp.EGGClass I
K912416Angiographic or Fluoroscopic X-Ray SystemXre Corp.IZIClass II
K912212Proact Cholesterol SystemsBoehringer Mannheim Corp.CHHClass I
K912179The Spritz BathThe Spritz Co.KTCClass I
K912074Bone Marrow Biopsy TrayArgon Medical Devices, IncGAAClass I
K912073Polaroid Helios Laser ImagerPolaroid Medical Corp.LMCClass II
K911829EndostapleEthicon, IncGCIClass II
K911273100 Cm Permanent Pacing Lead ModelsTelectronics Pacing Systems, Inc.DTBClass III
K911199Jms Av Fistula NeedlesJMS Co., Ltd.FIEClass II
K910924Endocardial Leads-Mod. to the PolyvinylpyrrolidonePacesetter SystemsDTBClass III
K910609Permanent Implantable Jp Endocardial Leads W/tipBIOTRONIK AGDTBClass III
K905198Diagnostic Ultrasound System Type 3535Bruel & KjaerIYNClass II
K901281Thermo Kor-Continuous Pulmonary Artery ThermometerVal-Mark Medical, Inc.DRBClass II
K897068Medtronic Minimax Hollow Fiber OxygenatorMedtronic, Inc.DTZClass II
K912363Electronic Ultrasound Scan Models Eup-U12/012t/tc3Hitachi Medical Corp. of AmericaITXClass II
K913429Emit(r) 2000 Phenytoin Assay/calibratorsSyva Co.DIPClass II
K913390M32 in-the-Ear Hearing AidPhilips Hearing Instruments Co.ESDClass I
K913389Philips S1594 Otb Hearing AidPhilips Hearing Instruments Co.ESDClass I
K913370Modification Manual Resuscitator (Pmr 2)Medtronic, Inc.BTMClass II
K913336Abuscreen(r) Online(tm) ControlsRoche Diagnostic Systems, Inc.LASClass I
K913335Abuscreen(r) Online(tm) CalibratorsRoche Diagnostic Systems, Inc.DKBClass II
K913330Urine Collection Kit/deviceMedical Implements, Inc.KHPClass I
K913252LiteboxSiemens Gammasonics, Inc.JAKClass II
K913198Kodak Ektachem Dt Slides (Che)Eastman Kodak CompanyDIHClass I
K913197Kodak Ektachem Dt Slides (Lac)Eastman Kodak CompanyKHPClass I
K913195Kodak Ektachem Dt Slides (Alb)Eastman Kodak CompanyCIXClass II
K913190Emit(r) 2000 Phenobarbital Assay/calibratorsSyva Co.DLZClass II
K913091Buehlmann Lab as, Ace Angio Conv Enzyme Kin AssayAmerican Laboratory Products CompanyKQNClass II
K912928Lifecare 4100 Pca Infuser Plus IIAbbott MedicalFRNClass II
K912896Digistore 2100Enhanced Imaging Technologies, Inc.JAAClass II
K912824Devon Sponge Counter BagsDevon Industries, Inc.LWHClass I
K912755Abuscreen Radioimmunoassay for AmphetamineRoche Diagnostic Systems, Inc.DJPClass II
K912704Atrium 2000 Chest DrainAtrium Medical CorporationKDQClass II