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 |
|---|---|---|---|---|---|
| K062027 | A&d Medical Ua-789 Digital Blood Pressure Monitor | A and D Engineering, Inc. | DXN | Class II | |
| K061670 | Lunderquist Wire Guide; Dc Wire Guide | William Cook Europe ApS | DQX | Class II | |
| K061042 | Linglock | Sybron Dental Specialties, Inc. | DYW | Class II | |
| K063732 | Microplasty Tibial Trays | Biomet Manufacturing Corp | JWH | Class II | |
| K063417 | Modification to Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K063211 | Proven Knee System High Flexion Tibial Insert | Globus Medical, Inc. | JWH | Class II | |
| K062877 | Twin-Pass .023 Dual Access Catheter, Model 5230 | Vascular Solutions LLC | DQO | Class II | |
| K062590 | Nuvasive Acp4 System | NuVasive Inc | KWQ | Class II | |
| K060305 | Hairmax Lasercomb | Lexington International, LLC | OAP | Class II | |
| K063744 | Cobas Integra C 111 | Rochdiag | CIG | Class II | |
| K063741 | Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K063739 | Sepramesh, Model 5959-1214 | Genzyme Corporation | FTL | Class II | |
| K063736 | Fuze Mechanical Wheelchair, Models T20 and T50 | Pdg Product Design Group Inc | IOR | Class I | |
| K063653 | Micrus Microcoil System, Cashmere Model Src | Micrus Endovascular Corporation | HCG | Class II | |
| K063621 | 3 Series Phototherapy Cabinet | Daavlin Co. | FTC | Class II | |
| K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | LLZ | Class II | |
| K063528 | Trocasys | Pajunk GmbH Medizintechnologie | GCJ | Class II | |
| K063438 | Vspspn | Tecres SpA | NDN | Class II | |
| K063429 | Gmd Universal Circumcision Clamp, Model 200 | Generic Medical Device, Inc. | HFX | Class II | |
| K063396 | Velure Family of Diode Lasers and Delivery Device Accessories | Lasering S.r.l. | GEX | Class II | |
| K063249 | Beamax | Medic Sharplight, Ltd. | GEX | Class II | |
| K063148 | Sock It! Oral Pain Gel | Merlin Group dba Mcmerlin Dental Company | OLR | Unclassified | |
| K062918 | Karl Storz Flexible Video-Urethro-Cystoscope System | Karl Storz Endoscopy-America, Inc. | FBO | Class II | |
| K062363 | Bwf-5 Medical Laser Series, 810 Nm; 930 Nm; 980 Nm; 1080 Nm | B&W Tek, Inc. | GEX | Class II | |
| K062358 | Modification to Vectorvision Trauma | Brainlab, Inc. | HAW | Class II | |
| K062009 | Aesculap-Meithke Progav Programmable Valve, Models Fv410t-Fv451t | Aesculap Inc | JXG | Class II | |
| K060465 | Premio | Peters Surgical | MXW | Class II | |
| K063688 | Surgical Irrigation System, Irrigation Tube | The Anspach Effort, Inc. | HWE | Class I | |
| K062978 | U2 Hip Stem, Ti Plasma Spray | United Orthopedic Corp. | LWJ | Class II | |
| K062775 | European Style Taper,press-Fit Hip Stem | Ortho Development Corp. | LPH | Class II | |
| K062181 | C-Jaws Cervical Compressive Mini Frame | Medicrea Technologies | KWP | Class II | |
| K063826 | Syngo Mi Applications 2007A | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K063812 | Straumann Prefgel | Straumann USA, LLC | KJJ | Unclassified | |
| K063747 | Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models Mfrn95-S, Mfrn95-Xs, Mfrn95-Ml, Mfrn95-a | Moldex/Metric, Inc. | MSH | Class II | |
| K063746 | Power Extenders Model# Pec200, Pes200,pes200s | Power Medical Interventions, Inc. | GDW | Class II | |
| K063721 | Nipro Safetouch II Gamma | Nipro Medical Corporation | FIE | Class II | |
| K063679 | Acl Top | Instrumentation Laboratory Co. | GKP | Class II | |
| K063554 | Meron Plus | Voco GmbH | EMA | Class II | |
| K063462 | Neatstitch Neatclose Suturing Device | Neat Stitch, Ltd. | GAM | Class II | |
| K063409 | Liberty Blood Glucose Monitoring System, Model 8000-0067 | Agamatrix | NBW | Class II | |
| K063370 | Cap 7.0Mm Mtp Resurfacing Hemi-Arthroplasty | Arthrosurface, Inc. | KWD | Class II | |
| K063345 | Spy Imaging System | Novadaq Technologies ULC | IZI | Class II | |
| K063309 | Tru-Cable | Truphatek International, Ltd. | FFS | Class II | |
| K063285 | Reliance Ci Process Indicator | Sybron Dental Specialties, Inc. | JOJ | Class II | |
| K063278 | Portland Cobalt Chrome Femoral Head | Portland Orthopaedics Pty., Ltd. | JDI | Class II | |
| K063217 | Venatech Lp Brachial Introducer System (Antecubital) | B.Braun Medical, Inc. | DTK | Class II | |
| K063170 | Tender Fiber | Micerium S.p.A. | EBI | Class II | |
| K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates | Biomet Microfixation | JEY | Class II | |
| K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | GXZ | Class II | |
| K062966 | Qms Lamotrigine Assay (Reagents), Calibrators & Controls | Seradyn, Inc. | ORH | Class II |