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 3257 of 3528
510(k) clearances, page 3257 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K812936Blood Pressure MonitorAmertekDXNClass II
K812909Hygientist; Cycloson I & II; RetrofitFibra Sonics, Inc.ELCClass II
K812660Terumo Hollow Fiber OxygenatorTerumo Medical Corp.DTZClass II
K812659Terumo Hollow Oxygenator CircuitTerumo Medical Corp.DTMClass II
K812444Radiation Sterilization for Needle CntrDevon Industries, Inc.GABClass I
K813304Conphar, Tuning ForksConphar, Inc.GWXClass I
K813276Ionescu-Shiley Valve Holder & HandleShiley, Inc.DTJClass I
K813160Beckman System E4aBeckman Instruments, Inc.JJEClass I
K813138Ethicon* Temp. Cardiac Pacing WireEthicon, IncLDFClass II
K813134Atrial Endocardial Electrode Lead J-TipTelectronics, Inc.DTBClass III
K813079Bipolar Optima Mp #255Telectronics, Inc.DXYClass III
K813028Poly-Flex Pacing LeadsIntermedics, Inc.DTBClass III
K813007Epcom Ems-180 Antepartum Fetal MonitorEpcom Medical Systems, Inc.HGMClass II
K81294010% Neutral Buffered Formalin ConcentSurgipathIFPClass I
K812610Siemens-Elema Pulse Generator 668 BSiemens Corp.DXYClass III
K811815Uropaper EikegSyn-Kit, Inc.KHEClass II
K813253Ic-5 VentilatorBio-Med Devices, Inc.CBKClass II
K813214Infant Phototherapy MaskMontrose Phototherapy SupplyFOKClass I
K813209Tracheobronchial Suction CatheterHydromer, Inc.BSYClass I
K813188Infant Phototherapy LightMontrose Phototherapy SupplyLBIClass II
K813161Flo Tem II (Blood/fluid WarmerDatachem, Inc.LGZClass II
K813155Pediatric Ventilator Circuit 2C7131Travenol Laboratories, S.A.BZOClass I
K813103Ackrad Incision & Drain SetAckrad LaboratoriesKDDClass I
K813095Gastric Juices Suction PumpEgnell, Inc.BTAClass II
K813075Tritec Doc TmTri-Tech, Inc.BZDClass II
K812853Osram Uva LampOsram GmbHIOBClass II
K812479Posture MirrorMaddak, Inc.LDQ
K811010Contact Lens MaterlParagon Optical Co.HPXUnclassified
K813298Conphar Delee Hillis StethoscopeConphar, Inc.HGNClass I
K813244UV Uric Acid DeterminationBiorent Diagnostic, Inc.CDOClass I
K813235Diss Female Air AdaptorTimeter Instrument Corp.BYKClass II
K813234Ohio Air AdaptorTimeter Instrument Corp.BYXClass I
K813229Hearing Aid Model Ue9-RUnitron Industries, Inc.ESDClass I
K813218Tdx VancomycinAbbott MedicalLEHClass II
K813215Y-GlutamyltransferaseAmerican Monitor Corp.
K813206Hearing Aid Custom IteDuvan Acoustics, Inc.ESDClass I
K813198Respirator MonitorFlorida Medical Equipment Repair, Inc.CCLClass II
K813159Vacushield TmGelman Sciences, Inc.JRLClass I
K813139Kodak Intensifying Screen So-168Eastman Kodak CompanyEAMClass I
K813124Ethicon* Skin Closure TapeEthicon, IncKGXClass I
K813073Omega 500 Rectangular Field Camera W/scTechnicare Corp.IYXClass I
K813065B.d.a.s.General Electric Co.KPTClass II
K812976Argyle Acc-U-Therm W/temperature ProbeSherwood Medical Co.BZTClass II
K812893SuperflabMick Radio-Nuclear Instruments, Inc.IYPClass I
K812869D-3260 Sorbent CartridgebioMerieux, Inc.FKTClass II
K812778The Telos EquipmentThe Telos Co.KQWClass I
K812613Vidicam 200Diversified P.A.IZJClass II
K811816Uropaper Eiken UhagSyn-Kit, Inc.JILClass II
K813269Two Piece Ostomy SystemHollister, Inc.EXBClass I
K813249Help-MateG & W Applied Science LaboratoriesESDClass I