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 |
|---|---|---|---|---|---|
| K083579 | Dimension Vista System Enzyme 6 Calibrator, Model Kc360 | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K083565 | Pigalileo Total Hip Replacement (Thr) Software Application V3.0 | Smith & Nephew, Inc. | HAW | Class II | |
| K083516 | Periogenix | Oroscience, Inc. | EMA | Class II | |
| K083399 | Ics Chartr Ep 200 | Natus Medical Denmark ApS | GWJ | Class II | |
| K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System | Abbott Medical | LZG | Class II | |
| K083051 | Flowtain & Flowtain Lv | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A | U. S. Diagnostics, Inc. | NBW | Class II | |
| K081540 | Zegra Posture Trainer | Peter Fischer | LZW | Unclassified | |
| K081479 | Advance a-Class Tibial Insert | Wrightmedicaltechnologyinc | MBH | Class II | |
| K081419 | Straumann Dental Implant System | Straumann USA, LLC | DZE | Class II | |
| K081400 | Fanning-Pappas Modular Knee Bearing | Endotec, Inc. | JWH | Class II | |
| K081255 | Scrambler St 5 TENS Device | Competitive Technologies,Inc. | GZJ | Class II | |
| K080874 | Easyra Alb Reagent and Easyra Alp Reagent, Model 10218/10214, Easyra Ast Reagent, Model 10206, Easyra CO2 Reagent | Medica Corp. | CIX | Class II | |
| K080853 | Duo-Care Blood Glucose and Blood Pressure Monitor System | Genexel-Sein, Inc. | NBW | Class II | |
| K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators | Siemens Healthcare Diagnostics Inc. | DDR | Class II | |
| K073439 | Transition Stabilization System | Globus Medical, Inc. | NQP | Class II | |
| K090296 | Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336 | Sport Medical Technology Inc | KPT | Class II | |
| K090276 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | DQO | Class II | |
| K090212 | Mac 800 Resting ECG Analysis System | GE Medical Syst. Information Technologies | DPS | Class II | |
| K083629 | Smoothshapes | Eleme Medical, Inc. | NUV | Class II | |
| K083600 | Vinyl Examination Glove, Powder-Free, Clear (Non-Colored) | Quantum Co., Ltd. | LYZ | Class I | |
| K083556 | Modification to Auto-Band Ligator | Scandimed International | MND | Class II | |
| K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails | Zimmer GmbH | HSB | Class II | |
| K083491 | Neuroscape | Olea Medical | LLZ | Class II | |
| K083488 | Jump S+ Trt, Jump Cic Trt, Jump S Trt, Jump C Trt | Audifon-USA, Inc. | KLW | Class II | |
| K083009 | Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000 | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | IYE | Class II | |
| K082124 | Carditte Microtel | Et Medical Devices SpA | DPS | Class II | |
| K090275 | Gelport Single Incision Access System | Applied Medical Resources Corp | GCJ | Class II | |
| K083735 | Ansha Autonomic Nervous System Health Assessment Plus | Medtechs, LLC | JOM | Class II | |
| K083383 | Vitek 2 Gram Positive Erythromycin for Streptococcus Pneumoniae | bioMerieux, Inc. | LON | Class II | |
| K083262 | Microscan Dried Gram -Negative Mic/combo Panels with Tigecycline (0.015- 32 Mcg/ml) | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K083252 | Nutorque Programmable Electric System | Dentalez Group, Stardental Division | EBW | Class I | |
| K082992 | Axxion Light Guide | Spinal Elements, Inc | FST | Class II | |
| K082791 | Ems Air-Flow Master | E.M.S. - Electro Medical Systems SA | EFB | Class I | |
| K082468 | Apex Hip System Bipolar Head, Model H3-822Xx and H3-828Yy, Xx=od in [Mm] (38-43), Yy=od in [Mm](44-60) | Omni Life Science, Inc. | KWY | Class II | |
| K082300 | Anatomic Locking Plating System | Depuy Orthopaedics Inc. | HRS | Class II | |
| K082117 | Quadrox-I Adult with and without Integrated Arterial Filter with Softline Coating, Model# Hmo 70000, Hmo 71000 | MAQUET CARDIOPULMONARY GmbH | DTZ | Class II | |
| K081137 | Intuitive Surgical Da Vinci Si Surgical System: Model Is3000 | Intuitive Surgical, Inc. | NAY | Class II | |
| K080733 | Cottons 100% Natural Cotton Tampons | Cottons Pty, Ltd. | HEB | Class II | |
| K090202 | Numeris Guided Coagulation System with Visitrax, Models Csk-121, -122, -123 and -125 | Ncontact Surgical, Inc. | OCL | Class II | |
| K090135 | Trimira Identafi 3000 | Remicalm, LLC | NXV | Class II | |
| K083855 | Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59 | Acumen Medical, Inc. | DYB | Class II | |
| K083745 | The Ic-Pro System, Model Version 3.2 | Paieon, Inc. | IZI | Class II | |
| K083639 | Muse Cardiology Information System with Vmware | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K083533 | Echelon C MRI System | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K083259 | Patient Vinyl Examination Gloves, Powderfree, Non-Sterile | Tangshan Zhongying Plastic Products Co., Ltd. | LYZ | Class I | |
| K082921 | Rad Source X-Ray Blood Irradiator, Model Rs-3400 | Rad-Source Technologies, Inc. | MOT | Unclassified | |
| K090269 | Airstrip Ob | AirStrip Technologies, Inc. | HGM | Class II | |
| K090016 | Powder-Free Vinyl Patient Examination Gloves | Suqian Clean Glove Co., Ltd. | LYZ | Class I |