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 3229 of 3528
510(k) clearances, page 3229 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K820296Stratus Tdm Control, Levels I,ii,iiiAmerican DadeDIFClass I
K821245Deseret Offset Prn AdapterWarner-Lambert Co.KGZClass I
K821191Ster-O-Mist 1000 MlInhalation Therapy Equipment, Co.CAFClass II
K821182Model ENT-4L-Flexible Nasopharyngo-Machida America, Inc.EQNClass II
K821181Flexible Nasopharyngo-Laryngoscope #Machida America, Inc.EQNClass II
K821166Kolor Kode TmDevon Industries, Inc.KDCClass I
K821154Kallestad Quantizyme Theophylline EnzymeJay Rau, Technical SuppprtKLSClass II
K821141Endab T4 Enzyme Immunoassay KitIMMUNOTECH s.r.o.CDXClass II
K821136Tdx Tm StreptomycinAbbott MedicalLEHClass II
K821132Model 28C Heaping AidTelex Communications, Inc.ESDClass I
K821128Disposable Thermoplastic Rubber MouthAirlife, Inc.BYPClass I
K821108Bi Plate-Xld/hektoen #30012Biomedia, Inc.JSIClass I
K821100Meritecastrep (Tm)Meridian Diagnostics, Inc.GTZClass I
K821054TotalAllerganHPXUnclassified
K821052SoakareAllerganHPXUnclassified
K821051Liquifilm Wetting SolutionAllerganHPXUnclassified
K820999Multiclip Disp. Ligating Clip DeviceDavis & Geck, Inc.FZPClass II
K820994Absorb Furn SheetAmerican Convertors Div., American PharmasealFPYClass I
K820987Foley Insertion Trays W/overwrayInmed Corp.KODClass II
K820958Digilog SystemMedical Design Laboratories, Inc.
K820906Spenco CryopressSpenco Medical Corp.IMDClass I
K820851Curity Economy II Cystoscopy TrayThe Kendal Co.FAJClass II
K821303Hi-Phore High Resolution ElectrophoresGelman Sciences, Inc.JJNClass I
K820850Curity Premium Cystoscopy TrayThe Kendal Co.KKXClass II
K820777Mini-Micro Arthroscopic ScapelThe Anspach Effort, Inc.HRXClass II
K820772Fetal-Tek Control (Immature/borderline)Helena Laboratories, Corp.JJXClass I
K820731Hematall-C Plus Hematology ControlsFisher Scientific Company L.L.C.JPKClass II
K820719The Icr KneeAmerican Ortomed Corp.
K820647Gamma Fetal Bleed Screening TestGamma Biologicals, Inc.LIMClass II
K820578Mezlin Diagnostic ReagentMiles PharmaceuticalsJTTClass II
K820253Simul-Fer Serum Iron Test KitDiagnostic Reagents, Inc.JJAClass I
K820199FetalscreenOrtho Diagnostic Systems, Inc.
K820838Curity Economy I CystoscopyThe Kendal Co.KODClass II
K821514Technicon Ra-1000 Sys, Analytes IIITechnicon Instruments Corp.JEJClass II
K821231Vivonex Tungsten Tip Tube PlacementNorwich Eaton Pharmaceuticals, Inc.KNTClass II
K821172External Female Urinary IncontinenceThe Healthcare Group Laboratories, Inc.KNXClass II
K821171Urinary Collection Container/leg BagThe Healthcare Group Laboratories, Inc.KNXClass II
K821161External Urinary Male Incontinence DevThe Healthcare Group Laboratories, Inc.KNXClass II
K821139Sps-Single Patient SystemExtracorporeal Medical Specialities, Inc.FIRClass II
K821138Ts-180 Series Tubing SetExtracorporeal Medical Specialities, Inc.FJKClass II
K821130Pediatric Urine CollectorAbco Dealers, Inc.
K821079Electroglottograph Naked Egg Boxed EggMs. Kate TeaneyKLXClass II
K821055Blink-N-CleanAllerganHPXUnclassified
K821022Precious Metal AlloysJ. Aderer, Inc.EJSClass II
K820979Resilient Gum ExerciserMartin A. Hass, D.D.S.JETClass I
K821147Cook #326T Program/telemetry BipolarCook Pacemaker Corp.DXYClass III
K821126Lister Bandage Scissors 3 & 1/2Conphar, Inc.FZTClass I
K821125Operating Scissors 5 &1/2 Sharp Blunt&Conphar, Inc.FZTClass I
K821124Scissors 6 & 1/2 Sharp/bluntConphar, Inc.FZTClass I
K821123Lister Bandage Scissors 7 & 1/2Conphar, Inc.FZTClass I