510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3165 of 3528
510(k) clearances, page 3165 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830818Asahi Blood/plasma Pump #Abp-01A &Parker Hannifin Corp.FIRClass II
K830816Dsl 1900Diagnostic SystemsCGIClass I
K830799Inductively-Coupled Plasma SpectrometerRevvity Health Sciences, Inc.JXRClass I
K830789Ames Tda Valproic Acid TestMiles Laboratories, Inc.LEGClass II
K830771Cadwell 8400Cadwell Laboratories, Inc.GWFClass II
K830768Disposable Skin StaplerSurgeons Choice, Inc.FZQClass I
K830762Olympus High Speed AnalyzerOlympus Corp.JJEClass I
K830745Adt Disposable Scalpel W/stainless SteelLab Industries, Inc.GDXClass I
K830734Forgarty Balloon CalibratorAmerican Edwards LaboratoriesDQOClass II
K830723Redi-DrapeThe Oec GroupKKXClass II
K830721Wire TwistersThe Anspach Effort, Inc.HTCClass I
K830704One Time Disposable Skin StaplerAcme United Corp.FZQClass I
K830677Blood Line Sets for HemofiltrationGambro, Inc.FJKClass II
K830613Electrosurgical Ground Pad-DispersiveCon Med Equipment, Inc.GEIClass II
K830527N.e.w. NebSan Diego Plastics, Inc.
K830519Challenger #450Transmed, Inc.DSHClass II
K830504Surgitek Ultra-Lo CuffMec/Surgitek ProductsBTRClass II
K830468Model 200Western Laboratories Corp.FTZClass I
K830434Disposable Intra-Articular BladeConcept, Inc.GFAClass I
K830397Pem-CHealth Development Corp.JSFClass I
K830339Imsi/metripond Hand Operating TableIntl. Management Services, Inc.FSEClass I
K830219Various Instruments & Instrument TraysAscep, Inc.FSMClass I
K830199Auto Suture Ta Dispos-Staple CartUnited States Surgical, A Division of Tyco HealthcGDWClass II
K830184Sphygmolog II Model DCardiodyne General, Inc.DXNClass II
K830165Bear Jet 150 VentilatorBear Medical Systems, Inc.FLIClass II
K830048Inflatable Penile Prosth. - CylinderAmerican Medical Systems, Inc.FAEClass II
K827708Ultrasonic Medical Device Model 3 Lo 4Sterisson
K823933Minidef (or DefiportOdamLDDClass II
K823931Defigard M(or Defiscope MOdamLDDClass II
K823849FreedomCarbonite Corp.IORClass I
K822990Convertors Primary Wound Dressing IIAmerican Hospital SupplyFROUnclassified
K822096Chemotherapy Infusion CatheterAmerican Heyer SchulteJCYClass I
K837252Digital Subtraction AngiogrpahyAster Medical, Inc.
K837202Kodak Ortho C Film So-344Eastman Kodak Company
K837201Kodak Lanex Fast Screens So-470Eastman Kodak Company
K830662Natural Lock Acetabular ComponentAdvanced Biosearch Assn.JDLClass III
K830966Playtex TamponsPlaytex, Inc.HILClass II
K830894H-H in-Line Valved Catheter 2 TypesHolter-Hausner Intl.JXGClass II
K830875S & W Model 29S & W Enterprises, Inc.JFBClass II
K830874S & W Model Sw 37S & W Enterprises, Inc.INQClass I
K830808Leeco T3-Ria Diagnostic KitLeeco Diagnostics, Inc.CDPClass II
K830805Knai Sodium Potassium AnalyzerRadiometer America, IncJSGClass I
K830785Leeco Dig-Quant Diag. Test KitLeeco Diagnostics, Inc.
K830783Veri-StaphZeus TechnologiesJWXClass I
K830780Koala C99 i.v. ControllerChesebrough-Pond'S U.S.A. Co.LDRClass II
K830732Netilmicin 30 Mcg Sensi DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K830731Netilmicin 30 Mcg Antimicrobial DiskGeneral DiagnosticsJTNClass II
K830705Mini Lancet-Blood LancetPharmaquest Corp.FMAClass I
K830698Quantum II Bacterial Ident. SystemAbbott MedicalJSSClass I
K830694Dupont Prep Type Cs Extraction CartrideE.I. Dupont de Nemours & Co., Inc.