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 2081 of 3531
510(k) clearances, page 2081 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K952421Nezhat-Dorsey Reusable Unipolar Coagulator Probe InsertsAmerican Hydro-Surgical Instruments, Inc.GCJClass II
K952214Sims Intertech Hyperinflation Bag SystemIntertech Resources, Inc.NHKClass II
K952192Karl Storz Unidrive Shaver, Arthroscopy BladesKarl Storz Endoscopy-America, Inc.HRXClass II
K952169Safe Response Mouth-to-Mask Resuscitator, PediatricIntertech Resources, Inc.BTMClass II
K952062Pft FilterIntertech Resources, Inc.CAHClass II
K952036FlexlifeMallinckrodt MedicalBYDClass I
K952007Adherol Sepp ApplicatorMedi-Flex Hospital Products, Inc.FROUnclassified
K951787Degubond 4Degussa AGEJTClass II
K951420Incase Extensible Bag--Non-SterileAlpha Surgical, Inc.LYUClass I
K951337Fiber Head Light Fh-300Neitz Instruments Company, Ltd.HPQClass II
K951147Leigh Med. Tech. Laryngoscope Blade CoverLeigh Med Tech, Inc.CCWClass I
K951109C-Thru Coronary Guide WireSchneider (Europe) GmbHDQXClass II
K951091Rusch Endobronchial Tube SetsRusch Intl.BTSClass II
K951065Surgical Instrument Mototrs and Accessories/attachmentsSteri-Oss, Inc.DZEClass II
K946257Latex Patient Examination Glove Powder Free (Hypoallergenic)Siam Sempermed Corp., Ltd.LYYClass I
K946209Dispodable Heat & Moisture Exchanger and Filter/hmeMed-Plastics Intl., Inc.BYDClass I
K944709W&h 896 Top Ligh HighspeedA-dec, Inc.EFBClass I
K952207Nasal Septal SplintSmith & Nephew Richards, Inc.LYAClass I
K951856Humid-Vent MicroGibeck, Inc.BYDClass I
K951678Hi Sonic 2000 Digital Hearing InstrumentHearing Innovations, Inc.LXBClass II
K951489Mri's All Silicone Gastrostomy TubeManufacturing & Research, Inc.KNTClass II
K951323Vh-2000Health Care Mfg., Inc.INQClass I
K951043Air-Soft-Disposable, Anesthesisa/respiratory Face MaskPromedic, Inc.BSJClass I
K950563Ultima Augmented Uhmwpe CupJohnson & Johnson Professionals, Inc.KWLClass II
K950529Peregrine Diffusion Light PipePeregrine Surgical, LLC.HJMClass II
K946237Electrosurgical Device, Cutting and Coagulation and AccessoriesMegadyne Medical Products, IncGEIClass II
K946159Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa KitIncstar Corp.LSEClass I
K946157Incstar Epstein-Barr Viral Capsid Antigen (Vca) Lgm Elisa KitIncstar Corp.LSEClass I
K945748Hycor Specific Ige Enzyme ImmunoassayHycor BiomedicalDHBClass II
K944908Holgrath Plastic-Hub, Coical Point Spinal NeedleHolgrath Medical Technologies, Inc.BSPClass II
K944907Holgrath Plastic-Hub, Quincke Spinal NeedleHolgrath Medical Technologies, Inc.BSPClass II
K944906Holgrath Plastic-Hub Epidural NeedleHolgrath Medical Technologies, Inc.BSPClass II
K944905Holgrath Plastic-Hub, Whitacre Style Spinal NeedleHolgrath Medical Technologies, Inc.BSPClass II
K944596Graham-Field Ultrasound LotionChester Labs, Inc.IMIClass II
K943862Sonicaid Model Mr-63 Ambulatory ECG RecorderOxford Instruments Medical SystemsDSHClass II
K943497Contrast 7000 Therapy SystemBurke Neutech, Inc.ILOClass II
K941234Non-Mydriatic Retinal CameraCanon Medical Components U.S.A., Inc.HKIClass II
K940715Osteonics Omnifit Ad Hip Stem SeriesOsteonics Corp.LPHClass II
K936310Orthomet Hmc Femoral Stem ComponentOrthomet, Inc.LPHClass II
K932880Grassi Gastrojejunostomy TubeBissell Medical Products, Inc.KNTClass II
K952122V-Gnathos PlusMetalor Dental USA Corp.EJTClass II
K951992Fairy World IncFairy World, Inc.HQYClass I
K951785Primallor 2Degussa AGEJTClass II
K951784Primallor 1Degussa AGEJTClass II
K951663Tytin RKerr Corporation (Danbury)EJJClass II
K951619Univec Nonreusable Locking SyringeUnivec, Inc.FMFClass II
K951569SurgactivatorDeschutes Medical Products, Inc.LJHClass II
K951210Welch Allyn Video OphthalmoscopeWelch Allyn IncHLIClass II
K951112Pressureguard IVSpan-America Medical Systems, Inc.FNMClass II
K950239Sensimatic 500SeParkell, Inc.EKZClass II