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 2994 of 3529
510(k) clearances, page 2994 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K851704ThermomedDraeger, Inc.FLLClass II
K851670Chem Trak Tri-Point Liquid Bilirubin Calibrator,i/Medical Analysis Systems, Inc.JITClass II
K851657Demand MagnesiumCooper Biomedical, Inc.JGJClass I
K851621Boom ArmDraeger, Inc.BSZClass II
K851620Spiromed 2Draeger, Inc.BZGClass II
K851598Thioglycollate without IndicatorPreferred Micro-MediaJSGClass I
K851568Emit 700 Benzodiazepine AssaySyva Co.JXMClass II
K851563Rk GencellsGenus DiagnosticsKIRClass I
K851562Mrc-5 GencellsGenus DiagnosticsKIRClass I
K851561Wi-38 GencellsGenus DiagnosticsKIRClass I
K851545Ultraclone Ecl-01-800 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K851542Rfa-300 Rapid Flow Analyzer W/computerAlpkem Corp.JJFClass I
K851521Ld-1(Immuno) Separation SetSeragen Diagnostics, Inc.CEXClass II
K851460New Connector & Cover for Telectronics 8Mm UnipolaTelectronics, Inc.BXYClass I
K851444Keith-A.r.v.Karl M. Block Co.KNTClass II
K851076Ubi Hcg-Magiwell Eia Early Pregnancy TestUnited BiotechJHIClass II
K850995Smart Alex Compact Clinical Analyzer(cca)(filter PAwareness Technology, Inc.JJQClass I
K850994Spectra 1 Filter PhotometerAwareness Technology, Inc.JJQClass I
K850859Cobas Calibrator SerumRoche Diagnostic Systems, Inc.JIXClass II
K850764Taucher Tunneler-Peripheral Vascular Surg-InstrumeAston & Aston
K850693Wsp Code 4315 PadtestWarne Surgical Products, Ltd.FAPClass II
K850543Theratron 780C a Radionuclide Radiation Therapy SyAtomic Energy of CanadaIWBClass II
K850529Sheer Adhesive Bandages, SterileAbco Dealers, Inc.KGXClass I
K850391Plasma Extraction SystemHans J. Brouwers & Assoc.JPIClass II
K850291Mueller Hinton Agar W/4% Nacl W/antibioticsRemel IncJTZClass II
K845029Surgical Power MagnetFriedman Labs, Inc.FTCClass II
K844813Mentor Expander Mammary ProsthesisMentorLCJUnclassified
K844644Surgical Laser Micro-TipsSurgical Laser Technologies, Inc.GEXClass II
K844643S.l.t. Laser Delivery Handles W/surgical RodsSurgical Laser Technologies, Inc.GEXClass II
K843915Mini-Halo CO2 Laser SystemCooperVision, Inc.GEXClass II
K842601Pre-Operative Ophthalmic Dressing TrayOphthalmic Resources, Inc.HOZClass II
K851883Simpson Obstetrical Forceps-Ss Type 410 or 420The Huxley Instrument Corp.HDAClass II
K851576Biggy Agar Nickersons MediumPreferred Micro-MediaJSHClass I
K851307Inox Dry Heat SterilizerBroadwest Corp.KMHClass II
K851055Sentinol -Orthodontic Arch WireGac Intl., Inc.DZCClass I
K850793Modified Anatomic Porous Replacement Apr AcetabulaIntermedics OrthopedicsJDLClass III
K850609Herpes Simplex Group Cf AntigenHillcrest BiologicalsGQNClass II
K850119Pharmaseal Eye Prep TrayAmerican Pharmaseal Div. AhscHNRClass I
K844440Model 4000 Nd:yag Laser for Hemorrhage ControlCooper Lasersonics, Inc.LKWClass III
K843276Iocare Converter KitChiron Vision Corp.HQCClass II
K842990Sterile Eye Surgery KitsBiological & Environmental Control LaboratoriesHOZClass II
K842647Cataract TrayDeRoyal Industries, Inc.HNNClass I
K851603Xylose Lysine Desoxycholate AgarPreferred Micro-MediaJSIClass I
K851602Urea AgarPreferred Micro-MediaJSHClass I
K851601Tryptic Soy BrothPreferred Micro-MediaJSGClass I
K851600Tryptic Soy Agar W/5% Sheep BloodPreferred Micro-MediaKZIClass I
K851599Trichomonas Broth (KupforbergPreferred Micro-MediaJSJClass I
K851579Chocolate Mueller Hinton AgarPreferred Micro-MediaJTYClass II
K851578Bile Esculin AgarPreferred Micro-MediaJSIClass I
K851577Bile Esculin Azide AgarPreferred Micro-MediaJSIClass I