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 |
|---|---|---|---|---|---|
| K073087 | Non-Contact Tonometer, Model Ft-1000 | Tomey Corporation | HKX | Class II | |
| K082568 | Saline Enhanced Electrosurgical Resection (Seer) Device | Apyx Medical Corporation | GEI | Class II | |
| K081981 | Lang Dental Acrylic Primer | Lang Dental Mfg Co, Inc. | EBI | Class II | |
| K080823 | Easyra Amylase, Bun, Glu-H, Trig, Uric Reagent | Medica Corp. | JFJ | Class II | |
| K080796 | Sri Lp Drape | Sri/Surgical Express | KKX | Class II | |
| K080623 | Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model Na | JAS Diagnostics/Drew Scientific | CHH | Class I | |
| K083207 | Ultrawave III Ex 1320 | Quanta System Inc. | GEX | Class II | |
| K083071 | Vertex Reconstruction System | Medtronic Sofamor Danek | KWP | Class II | |
| K083018 | Centricity Pacs Web Diagnostic | GE Healthcare Dynamic Imaging Solutions | LLZ | Class II | |
| K082581 | C-Quest | Medx, Inc. | KPS | Class II | |
| K082434 | Gdls-200 | GC America Inc. | EBF | Class II | |
| K082430 | Syngo Imaging Xs | Siemens AG Medical Solutions | LLZ | Class II | |
| K082381 | Genex | Biocomposites, Ltd. | MQV | Class II | |
| K082322 | Air Assisted Sprayer, Models: Airsprayus01 and Airsprayus | Medtronic, Inc. | GCJ | Class II | |
| K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | OMP | Class II | |
| K082176 | Ltm-Bps Surgical Mesh | LifeCell Corp | FTM | Class II | |
| K082128 | Depuy Spine Lateral Cage System | DePuy Spine, Inc. | MAX | Class II | |
| K082108 | Obc Bone Anchored Hearing Aid System | Oticon Medical AB | LXB | Class II | |
| K081986 | Safesept Transseptal Trocar Guidewire | Oscor Inc. | DRC | Class II | |
| K081906 | Protex CT Cervicothoracic Spinal System | Globus Medical, Inc. | KWP | Class II | |
| K081805 | Cuffalert | Sunmed, Inc. | BSK | Class II | |
| K081673 | Dyn-Alif Anterolateral Intervertebral Body Fusion Device | Ionics Medical Corp. | MAX | Class II | |
| K081335 | Tenacore Oxygen Blender, Model Tb-2000 | Tenacore Holdings, Inc. | BZR | Class II | |
| K081123 | Nexus i.v. Needless Access Cannula for Intravascular Administration Sets | Nexus Medical, LLC | FPA | Class II | |
| K080591 | Tanda Skincare System, Model: Ptscs | Pharos Life Corporation | GEX | Class II | |
| K080460 | Spectral Oct/slo | Opko Health, Inc. | OBO | Class II | |
| K083069 | Ezlase 10W | Biolase MG LLC | GEX | Class II | |
| K083035 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | NZT | Class II | |
| K083028 | Modification to: Nuvasive Spherx II System | NuVasive Inc | NKB | Class II | |
| K082971 | Bonart Art-L5 LED Cordless Curing Light | Bonart Co. Ltd. | EBZ | Class II | |
| K082803 | Coaxial Accordion Stone Management Device, Model: Coac12005 - Coa20015 | Percutaneous Systems, Inc. | FFL | Class II | |
| K082734 | A&d Medical Ua-851Thw Digital Blood Pressure Monitor | A and D Engineering, Inc. | DXN | Class II | |
| K082392 | Evotech Endoscope Cleaner and Reprocessor | Advanced Sterilization Products | FEB | Class II | |
| K082187 | Biomet Anterior Lumbar Plate | Ebi, LLC | KWQ | Class II | |
| K082142 | Acuson S2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound di | IYN | Class II | |
| K082126 | Rhapsody MRI | Grantadler Corporation | LJT | Class II | |
| K081818 | Biolok Micro-Lok Implant System | BioHorizons Implant Systems Inc | DZE | Class II | |
| K080723 | Sri Lp Gown | Sri/Surgical Express | FYA | Class II | |
| K080707 | Sri Plr Gown | Sri/Surgical Express | FYA | Class II | |
| K080442 | Seriscaffold Surgical Mesh | Serica Technologies, Inc. | FTL | Class II | |
| K073689 | Lep2000 Therapy System | International Medical Instruments, Inc. | NHN | Class II | |
| K083190 | D-Stat Dry Wrap Hemostatic Bandage, Model: 3015 | Vascular Solutions LLC | QSX | Unclassified | |
| K082763 | Diazyme Liquid Stable Enzymatic Sodium Assay, Model Dz114b | Diazyme Laboratories, Inc. | MZU | Class II | |
| K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | JCX | Class II | |
| K081889 | Rhapsody CT | Grantadler Corporation | LJT | Class II | |
| K080532 | Benacel, Models C-001, C-002 and C-005 | Unicare Biomedical, Inc. | QSY | Unclassified | |
| K080503 | Silver Alginate IV Antimicrobial Wound Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies Ltd. | GEX | Class II | |
| K082641 | Fingertip Pulse Oximeter, Models Cms-50D, Cms-50L, Cms-50Dl | Contec Medical System Co., Ltd. | DQA | Class II | |
| K082624 | Synthes (USA) 3.5Mm Lcp Posteromedial Proximal Tibia Plates | Synthes (USA) Products LLC | HRS | Class II |