510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3340 of 3526
510(k) clearances, page 3340 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K801593Lebody by Water PikTeledyne, Inc.ISAClass I
K801575L-Cath Intravenous Placement UnitLuther Medical Products, Inc.FOZClass II
K801564Photometer Lp 1Dr. Bruno Lange GmbHJJQClass I
K801563Photometer Lp 3Dr. Bruno Lange GmbHJJQClass I
K801562Photometer Lp 6Dr. Bruno Lange GmbHJJQClass I
K801542Sunbed/sunroof or Suncouch/sunskySunfit, Inc.LEJClass II
K801541Wall Mounted Laser Positioning DeviceAdvantage Medical Systems, Inc.IWEClass I
K801521Classic Tan Tanning BoothClassic Tan, Inc.LEJClass II
K801520Solar Pacific Uva Sunlamp DeviceSolar PacificLEJClass II
K801512Doppler Ultrasonic StethoscopeMountain Medical Equipment, Inc.IYNClass II
K801507Antigen Control CellsOrtho Diagnostics, Inc.GOLClass II
K801500Ultrafree Calcium FilterEMD Millipore CorporationJRLClass I
K801481Bmc Riaflo SystemBoehringer Mannheim Corp.JJCClass I
K801459Electro-Acuscope-70Nebrensky Corp.GZJClass II
K801415Latex Foley Catheter (Hydromer Coated)G.D. Searle and Co.KODClass II
K801331Ampco Hyperalimentation Subclavian TraysAssociated Medical Products Co.FRGClass II
K801880Mmi/gaeltec Series 8T Diff. Press. TransMedical Measurements, Inc.BYRClass I
K801875Circuits, Breathing W/connectors, AdaptAirlife, Inc.CAFClass II
K801814Catheter Suction TracheobronchialConcord Laboratories, Inc.BSYClass I
K801758Mmi/gaeltec Catheter IntrauterineMedical Measurements, Inc.KXOClass II
K801692Rionet Hearing Aid And/or Rion #Hb-70Rion Acoustic Instruments, Inc.ESDClass I
K801622Adel Medical Birthing Bed, Mod. Ld-400Adel Medical, Ltd.KNCClass II
K801576Neurogar III-Transcut. Elec. Nerve StimInter Med Industries, Inc.GZJClass II
K801450Intermedics Thin Lith IV Series UnipolarIntermedics, Inc.DXYClass III
K801357Modified Blood Cell Counting & LysingCoulter Electronics, Inc.GIFClass I
K800696Electronic Pacemaker Waveform AnalyzerInstromedix, Inc.KREClass II
K801858Oxymeter & TransoxodeThoracelKLHClass I
K801855Cyclopac TENSDow Corning WrightGZTClass II
K801853Parallel-a-PrepC.D. Charles, Inc.EGIClass I
K801847Triple Sugar Iron Agar(micro/cult/mediaRadiation Technology, Inc.JSHClass I
K801821Flow Med 150D.R.O. Medical, Inc.FPAClass II
K801809Orthodontic Bracket/speed/hanson SpeedStrite Industries, Ltd.EJFClass I
K801804Anesthesia Bacteria FilterOmnicon Medical Corp.CAHClass II
K801803Mainflow Bacteria FilterOmnicon Medical Corp.CAHClass II
K801796The Comfort LiftGettner Enterprises, Inc.FMRClass I
K801794Elastic Adhesive Bandages(sterile)Smith & Nephew, Inc.KGXClass I
K801784Urinary Catheters #3400,3410 &3420The Healthcare Group Laboratories, Inc.KODClass II
K801783Catheter Irrigation Trays, #3300, 3310 &The Healthcare Group Laboratories, Inc.EYNClass II
K801782General Purpose Irrigating/aspir Syr.The Healthcare Group Laboratories, Inc.KQTClass II
K801781Catheter Irrigation Syringes, #3100,3110The Healthcare Group Laboratories, Inc.KQTClass II
K801764Ionescu-Shiley Pericardial PatchShiley, Inc.DXZClass II
K801755Mmi/gaeltec Catheter Tip PressureMedical Measurements, Inc.GWMClass II
K801747Terumo Fetal Monitor # Fhm-602Terumo Medical Corp.HGMClass II
K801742New Fine Model ENT Treatment UnitJEDMED Instrument CompanyETFClass I
K801741Pretty Model ENT Treatment UnitJEDMED Instrument CompanyETFClass I
K801740Treatment Unit for Doctor's RoundsJEDMED Instrument CompanyETFClass I
K801739Noble Model Doublesided Treatment UnitJEDMED Instrument CompanyETFClass I
K801738Noble Medel ENT Treatment UnitJEDMED Instrument CompanyETFClass I
K801731C-Dak Duo-Flux Artificial KidneyCordis US Corp.KDIClass II
K801730Krymed System 4001 Tilt ScopeCryomedics LLCHEXClass II