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 |
|---|---|---|---|---|---|
| K061880 | Acceli Dbm Family Products, 0.5Cc, 1Cc, 2.5Cc, 5Cc, 10Cc, 15Cc, 30Cc | Isotis NV | MQV | Class II | |
| K072079 | Iguide System | Medical Intelligence Medizintechnik-GmbH-An Elekta | IYE | Class II | |
| K072066 | 1.3M Monochrome Lcd Monitor Mdl1908a | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K072065 | 20.8-Inch (53Cm) Color Lcd Monitor Cdl2119a (Ccl352i2) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K071952 | Graftlock Screw, St Screw | Biocomposites, Ltd. | HWC | Class II | |
| K071925 | Magnetom Essenza | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K071923 | PTFE Flixene Graduated Wall Graft | Atrium Medical Corporation | DSY | Class II | |
| K071753 | Masterscreen Pneumo & Masterscope | Viasys Healthcare GmbH | BTY | Class II | |
| K071710 | Bengay (R) Heat Therapy, Pain Relieving Patches/pads (Various) | Johnson & Johnson Consumer Products, Inc. | IMD | Class I | |
| K071033 | T2 Xvbr Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | FDF | Class II | |
| K071094 | Modification to Solar Gi | Medical Measurement Systems B.V. | FFX | Class II | |
| K071035 | Ifs Bone Fixation Devices | Internal Fixation Systems, Inc. | HWC | Class II | |
| K070371 | Fingertip Pulse Oximeter Md300c | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | |
| K062974 | Tesla Nibp | Mammendorfer Institut Fur Physik und Medizin GmbH | DXN | Class II | |
| K072119 | Airlife Nebulizer Cap | Cardinalhealth | CAF | Class II | |
| K072070 | Philips Mp2 and X2 Intellivue Patient Monitors | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | MHX | Class II | |
| K071943 | Serenity Pro Psf System | Inolase 2002, Ltd. | GEX | Class II | |
| K071933 | Endowave Infusion System | Ekos Corp. | QEY | Class II | |
| K071722 | Deep Blue | E.M.S. - Electro Medical Systems SA | EBZ | Class II | |
| K071628 | Stryker External Fixation System | Stryker Cmf | MQN | Class II | |
| K071529 | Xtract Catheter System | Lumen Biomedical, Inc. | QEZ | Class II | |
| K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502X | Core Essence Orthopaedics, LLC | MBI | Class II | |
| K071500 | Nano-Bond II Adhesive System | Pentron Clinical Technologies | KLE | Class II | |
| K071327 | Memo 3D Semirigid Annuloplasty Ring | Sorin Biomedica Cardio S.r.l. | KRH | Class II | |
| K071213 | Camlog Logfit Prosthetic System | Altatec GmbH | NHA | Class II | |
| K070913 | Self-Light Disposable Anoscope | Sapimed S.p.A. | FER | Class II | |
| K070911 | Std Med Primo Port | Std Med, Inc. | LJT | Class II | |
| K071944 | Acumed Small Bone Locking System II | Acumed LLC | HSB | Class II | |
| K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia 500, Xbia 900 | Jawon Medical Co., Ltd. | MNW | Class II | |
| K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | |
| K071674 | Gc-Zirconia | GC America Inc. | EIH | Class II | |
| K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | LLZ | Class II | |
| K071481 | Healix Anchor | DePuy Mitek, Inc. | HWC | Class II | |
| K070389 | Peek Knotless Anchors | Biomet Sports Medicine | HWC | Class II | |
| K063771 | Glucocard X-Meter Blood Glucose Monitoring System | Arkray Factory USA, Inc. | NBW | Class II | |
| K072052 | Osteograf/d-300 | Dentsply International, Inc. | LYC | Class II | |
| K072037 | Careo Safety Syringe for U-100 Insulin 0.5Cc/ml | Life-Shield Products, Inc. | MEG | Class II | |
| K071953 | Rtx3370 | Rtx Healthcare A/S | DRG | Class II | |
| K071857 | Delta Spinal Fusion System | Jemo Spine, LLC | MNI | Class II | |
| K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | HRS | Class II | |
| K071540 | Sbi Titanium Threaded Pin | Small Bone Innovations, Inc. | JDW | Class II | |
| K071509 | BIPAP Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | MNS | Class II | |
| K071415 | Digital Pulse Oximeter, Model 7500Fo | Nonin Medical, Inc | DQA | Class II | |
| K071335 | Medpor Attractor Implant | Porex Surgical, Inc. | HPZ | Class II | |
| K071329 | Nuvasive Helix Acp System | NuVasive Inc | KWQ | Class II | |
| K071298 | HF Junior Hemofilter | Medivators Inc | KDI | Class II | |
| K071247 | N Latex RF Kit | Siemens Healthcare Diagnostics Inc. | DHR | Class II | |
| K071039 | Mission Olympus Au Ise Calibrators | DIAMOND DIAGNOSTICS Inc | JIT | Class II | |
| K070341 | Ldr Spine Easyspine Posterior Osteosynthesis System | Ldr Spine USA | KWP | Class II |