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 2974 of 3529
510(k) clearances, page 2974 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K851128Digitmatic Dm2Medimatic S.r.l.JOMClass II
K850924Jee Frame (Ventilator Circuit Support)Vulcan Laboratories, Inc.JAYClass I
K850151L100b Universal & L100a Night Patient CircuitLife Products, Inc.BZOClass I
K844119Mammograph IIIAmerican Medical Imports, Inc.IZHClass II
K852554Srt-SystemMicrowave Development, Inc.JPHClass I
K852160Radiological Marking PenTruett Laboratories, Inc.JACClass I
K852089Saturn Nuclear Medicine Computer SystemTechnicare Corp.IYXClass I
K851041Adac Models Xl-Plan 23 & Xl-Plan 73Philips North America LLCIYEClass II
K850269Meritec-Totavirus Latex Detection ProcedureMeridian Diagnostics, Inc.LIQClass I
K852432Suprima II Model 254-28Intermedics, Inc.DXYClass III
K852430Suprima II Model 253-23Intermedics, Inc.DXYClass III
K851937Sonomed 4Robert Bosch Corp.IMIClass II
K851331Empi Model 100, Cpm(power Excerise Equipment)EmpiBXBClass I
K851328Kinetic Auto Technic K.a.t. TableBuckman Co., Inc.JFBClass II
K850430Neuroscience Map-10 EEGNeuroscience, Inc.GWSClass I
K852674Stryker 988 ICU BedStryker Corp.FNLClass II
K852423Timentin 85Mcg Sensitivity DiscDifco Laboratories, Inc.
K852361Intravenous Injection SetThe West Co., Inc.FPAClass II
K852059The P.c.a. Dome Patella ComponentHowmedica Corp.JWHClass II
K851804Bio-Challenge Test PakPropper Mfg Co IncJOJClass II
K851467Hemoglobin AnalyzerAwareness Technology, Inc.KHGClass II
K851205CementrifugeBiodynamic Technologies, Inc.JDZClass I
K851103Vascular Implant Access Needle SetBaxter Healthcare CorporationFMIClass II
K850822Chronocor V External Pacer, Model 297ASeamed Corp.DTEClass II
K850077Medtronic 5311 Pacing System AnalyzerMedtronic, Inc.DTCClass II
K841407Isogel AgaroseFmc Corp.JJNClass I
K852735Scalpel Handle #7 Ss 410 or 420The Huxley Instrument Corp.GDZClass I
K852734O.r. Scissors, Straight, 5-1/2+Shp/shp SsThe Huxley Instrument Corp.
K852732Iris Scissors, Curved, 4-1/2+Ss 410 or 420The Huxley Instrument Corp.
K852731Lister Bandage Scissors, 5-1/2+Ss 410 or 420The Huxley Instrument Corp.
K852730Crile Forceps, Striaght, 6-1/4+Ss 410 or 420The Huxley Instrument Corp.GENClass I
K852729Aalstead Mosq. Forceps, Straight, 5+Ss 410 or 420The Huxley Instrument Corp.HTDClass I
K852728Kelly Hemostatic Forceps, Straight 5-1/2+SsThe Huxley Instrument Corp.HTDClass I
K852727Rochester - Pean Forceps, Straight, 6-1/4+SsThe Huxley Instrument Corp.HTDClass I
K852724Backhaus Towel Clamp, 5-1/2 + Ss 410 or 420The Huxley Instrument Corp.GDJClass I
K852723Foerster Sponge Forceps, Serrated, 7+Ss 410 or 420The Huxley Instrument Corp.HTDClass I
K852722Sterilizing Forceps, 3-Pronge, 11+Ss 410 or 420The Huxley Instrument Corp.HTDClass I
K852720Thumb Dressing Forceps, 5+Ss 410 or 420The Huxley Instrument Corp.HTDClass I
K852719Mayo Hegar Needle Holder, G+ss 410 or 420The Huxley Instrument Corp.
K852718Adson Tissue Forceps, 1X2 Teeth 4-3/4+SsThe Huxley Instrument Corp.HTDClass I
K852717Iris Forceps, Delicate, 1X2 Teeth, Straight, 4XssThe Huxley Instrument Corp.GENClass I
K852715Magill Forceps, Adult, 10 + Ss 410 or 420The Huxley Instrument Corp.HTDClass I
K852714Mayo Dissecting Scissors, Straight, 5-1/2 + SsThe Huxley Instrument Corp.
K852713Russian Tissue Forceps, 6 + Ss 410 or 420The Huxley Instrument Corp.HTDClass I
K852712Mayo Scissors, 6-3/4 Curved Ss 410 or 420The Huxley Instrument Corp.
K852711Scalpel Handle #3 Ss 410 or 420The Huxley Instrument Corp.GDZClass I
K852692Respitrace 300ScRespitrace Corp.BZKClass II
K852666Identicult-AeScott Laboratories, Inc.JTOClass I
K852657Amresco Calcium Reagent SetAmerican Research Products Co.CICClass II
K852589Tdx Immunoglobulin G Diagnostic KitAbbott MedicalDEWClass II