510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 of the 176,466 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
20262,669
176,466 records, page 2723 of 3530
510(k) clearances, page 2723 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K882346Instrument Protect-a-Caps, Aka: Tip/instru. GuardNordbye, Milchman, BarlageFYFClass I
K882323Meicor X-Ray Tube, Models Mc1000, Mc1500, Mc2000Meicor, Inc.ITYClass I
K881511Fixator Pin (External)Mizuho Orthopedic Systems IncJDWClass II
K881448#557 Disposable Cardiovascular ClampAlpha Industries, Inc.DXCClass II
K881349Verruca-Freeze(tm) Cryotherapy Delivery SystemCryosurg, Inc.GEHClass II
K882405Hypodermic Needle Sheath HolderAnsr Ent., Inc.FMJClass II
K882241Kirschner (R) Unicondylar-II Knee SystemKirschner Medical Corp.HRYClass II
K881458Astroscan 2100 Microtiter Plate ReaderAstroscan, Ltd.JJQClass I
K881289Corin Bipolar ProsthesisMizuho Orthopedic Systems IncKWYClass II
K881288Corin Modular Moore StemMizuho Orthopedic Systems IncLWJClass II
K880919(Choice) Also (Kondum)Select Sources, Inc.HISClass II
K880435Proforma/ps Total Hip SystemOrthomet, Inc.JDIClass II
K880295Cannula Model Ar-6001Arthrex Arthroscopy Instruments, Inc.HRXClass II
K882499Jayco Hydrogen MonitorEnteron, Inc.NRHClass I
K882430Hood Tracheal Stoma ButtonHood LaboratoriesBTOClass II
K882351Mueller Hinton Agar Plates P3318/1&2/p3418/p34181Lakewood Biochemical Co., Inc.JTZClass II
K882339Bio*nephross I.q. AndantebioMerieux, Inc.FJIClass II
K882328Hi Flow 50Minnesota Valley Engineering, Inc.BYJClass II
K882215Nephross I.q. ModeratobioMerieux, Inc.FJIClass II
K882213Nephross I.q. AllegobioMerieux, Inc.FJIClass II
K882184Hr-1000 W/suffixes (B,c or D)EigenLMBClass I
K881980Retroject(tm) Anti-Aids Syringe W/retrac. NeedleHabley Medical Technology Corp.FMFClass II
K881964Msi 3003 Series BedMed Service, Inc.FNJClass I
K881963Msi 3002 Series BedMed Service, Inc.FNLClass II
K881091Omnisil, Vinyl Polysiloxane Impression MaterialCoe Laboratories, Inc.ELWClass II
K880688Slc Hard Lens CleanerOcular Pharmaceuticals, Inc.LPNClass II
K880666Ultraviolet Light Protectve EyewereFree Sun Intl. ABHOYClass I
K875160Rigel Model Multicare 409Rigel Medical Electronics, Inc.DRTClass II
K882253Stoute's Assist-Seat Wheelchair ComponentStoute'S "Assist-Seat" Corp.KNNClass I
K8819883M Wound Contact Material, Product #563X3M CompanyNADClass I
K881788Ktp/532(tm) Surgical LaserLaserscopeGEXClass II
K881683Dideco-Shiley Autotrans Bt 795/AaShiley, Inc.CACClass II
K881367Acl Systems 100, 200, 300 and 300+ Coagulation SysInstrumentation Laboratory Co.JPAClass II
K881358Pg Consen Contrast Sensitivity Testing ProgramNeuroscientific Corp.HOXClass I
K880484Surgical GarmentsGreene International Corp.FYCClass II
K880189New JelliacoatK&G Import/Export Co.HISClass II
K882465Model 172-P and 172-N Rotary Spray ArmBoling Precision Components Co.FLEClass II
K882173Delfia Estradiol KitPharmacia, Inc.CHPClass I
K882172Saracap AgPpg/Applied Resources, Inc.CCKClass II
K882116Total Protein/albumin StandardVerichem Laboratories, Inc.JIXClass II
K882038Gds Enzymatic Salicylate ReagentGds Technology, LLCDKJClass II
K881833Nasal CPAP SystemHealthdyne, Inc.BYEClass II
K881657Humid-Vent FilterGibeck RespirationBYDClass I
K881102Micromedic Morphine Ria KitIcn Micromedic SystemsDOEClass II
K881093ICU SaracapPpg/Applied Resources, Inc.CCKClass II
K880963Hac Autology Centers Dispensing Kit for Fib.con.Buckman Co., Inc.FMFClass II
K880759Modified Digital Clinical ThermometerEpson America, Inc.FLLClass II
K880618Fertility Forecaster Computer ProgramFertile Time, Ltd.LHDUnclassified
K875219Modification to Kdi Quik Test Marijuana ScreenKeystone Diagnostics, Inc.LDJClass II
K875042Nd:yag 100 Surgical Laser for Neuro & PulmonarySurgilase, Inc.LKWClass III