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 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K922733 | Perfecta Total Hip System and Proforma Total Hip | Orthomet, Inc. | JDI | Class II | |
| K920569 | Indxtm Dip-S-Tickstm | Intercare Diagnostics, Inc. | LSQ | Class I | |
| K915554 | Hi-Torque Sport-T(tm) Guide Wire | Peripheral Systems Group | DQX | Class II | |
| K915424 | Arthrex Cannulated Interference Screw | Arthrex GmbH | HWC | Class II | |
| K914273 | A&d Tm-2421/2021 Ambulatory Blood Pressure Monitor | A and D Engineering, Inc. | DSK | Class II | |
| K926198 | Access Total Bhcg Assay | Bio-Rad Laboratories Inc. | JHI | Class II | |
| K925879 | Microvasive Insurg Flat Wire Baskets | Boston Scientific Corporation | LQR | Class II | |
| K925603 | Olympus Cholesterol Reagent | Olympus Corp. | CHH | Class I | |
| K925600 | Vista 4000 Sigma | Unitron Industries, Inc. | ESD | Class I | |
| K925455 | Arthrex Atraumatic Mini-Grasper | Arthrex GmbH | HRX | Class II | |
| K924368 | Olympus Albumin Reagent | Olympus Corp. | CIX | Class II | |
| K924363 | Vacuplus(r) Star-Sep(tm) | Starplex Scientific Corp. | JKA | Class II | |
| K924075 | Disposable Optical Valvulotome | Endovascular, Inc. | MGZ | Class II | |
| K923638 | Acessory Pack | Medtronics Interventional Vascular | LIT | Class II | |
| K922890 | Arthrex Knee Arthroscopic Surgery Accessories | Arthrex GmbH | HRX | Class II | |
| K922116 | Powder Free Nitrile Glove | Hpi, Inc. | KGO | Class I | |
| K921800 | Colonoscopic Injection Needle, C-323/C-325 | Mill-Rose Laboratory | FBK | Class II | |
| K920118 | Resorabplug | Sofamor Danek Mfg., Inc. | LZN | Class II | |
| K926306 | Foot Control Pencil | Megadyne Medical Products, Inc | GEI | Class II | |
| K925880 | Kodak Amerlite Ck-Mb Control Sera Lan.4413 | Eastman Kodak Company | JJX | Class I | |
| K925863 | Spuncrit | bioMerieux, Inc. | GKG | Class II | |
| K925626 | Maxima Plus Hollow Fiber Oxygenator | Medtronic, Inc. | DTZ | Class II | |
| K925528 | Biovation K-Manager | Biovation, Inc. | GKZ | Class II | |
| K925412 | Electromedics Tissue Trap/ #Tt280 | Electromedics, Inc. | BYZ | Class II | |
| K925339 | Olylmpus Alanine Aminotransferase Reagent | Olympus Corp. | CKA | Class I | |
| K925194 | Thyroglobulin Auto-Antibody Eia Test Kit | Joldon Diagnostics | JZO | Class II | |
| K925188 | Abbott Quickstart Ld-1, Modification | Em Diagnostic Systems, Inc. | JGF | Class II | |
| K925181 | Techmedica Mueller Type Polyethylene Acetbul Cup | Techmedica, Inc. | JDL | Class III | |
| K924894 | Autovac 7900 Series | Boehringer Laboratories, LLC | CAC | Class II | |
| K924725 | American Biomed, Inc. Microsurgical Instruments | American Biomaterials Corp. | MDM | Class I | |
| K924703 | Lactate Dehydrogenase (Ld) Test Item #65418 | Em Diagnostic Systems, Inc. | CFJ | Class II | |
| K924578 | Psa Antibody Kit | Ventana Medical Systems Inc | DFD | Class II | |
| K924530 | Cabot Medical Niagara(tm) 3.0 Liter High Flow Irri | Cabot Medical Corp. | HET | Class II | |
| K924503 | Personna Safety Scalpel | American Safety Razor Co. | MDM | Class I | |
| K924490 | Masterstim I-2 | Health Care Assoc. | LIH | Class II | |
| K924444 | B-4 Four-Way Radiographic Table | Control-X, Inc. | IZZ | Class II | |
| K924443 | Rs-3 Universal Radiographic Working Place | Control-X, Inc. | IZF | Class II | |
| K924369 | Ils(tm) - Invasive Line Separator | 2-Rn Corp. | KMK | Class I | |
| K924170 | Isolette Incubator Humidity Meter | Air-Shields, Inc. | FMZ | Class II | |
| K924166 | Optilink(tm) Lpm (Laser Power Modulator) | Xintec Corporation | GEX | Class II | |
| K924114 | Histofreezer | Solarcare Technologies Corp,Inc. | GEH | Class II | |
| K923945 | Pleatman Sac Specimen Container | Cabot Medical Corp. | GCJ | Class II | |
| K923773 | Cellexis Hematology Analyzer | Technalysis, Inc. | GKZ | Class II | |
| K923762 | Spur Infant/child W/o Pressure-Limiting Valve | Ambu, Inc. | BTM | Class II | |
| K923464 | Urodynamic Catheters | R.L. Medical Corp. | FAP | Class II | |
| K923079 | Il Test Calibration Set Apo A1b | Instrumentation Laboratory Co. | DFC | Class II | |
| K922745 | Cyto-Stat/coulter Clone Cd3(igg1)-Fitc/t4-Rd1 | Coulter Immunology | GKZ | Class II | |
| K922744 | Cyto-Stat/coulter Clone Cd 3(Igg1)-Fitc/t8-Rd1 | Coulter Immunology | GKZ | Class II | |
| K922382 | Intermate(r) Lv Elastomeric Infusion Device | Baxter Healthcare Corporation | MEB | Class II | |
| K922281 | Illuminator VII Mini/spot Light | Medical Illumination, Inc. | KZF | Class I |