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 |
|---|---|---|---|---|---|
| K070209 | Fb-100U Series Digital Blood Pressure Monitor | Fego Precision Industrial Co., Ltd. | DXN | Class II | |
| K063086 | Transferrin, Specical Calibrator, Specitrol and Specitrol High Controls | Thermo Electron Oy | DDG | Class II | |
| K072010 | Quantum Direx System | Quantum Medical Imaging, LLC | KPR | Class II | |
| K071963 | Modification to: Arthrocare Arthrowands | ArthroCare Corporation | GEI | Class II | |
| K071775 | Dash | Ezsurgical | GAD | Class I | |
| K071709 | Arthrocare System 12000 | ArthroCare Corporation | GEI | Class II | |
| K071549 | Sbi Rhead Plating System | Small Bone Innovations, Inc. | HRS | Class II | |
| K071207 | Master Guard Nitrile Blue Powdered Examination Gloves | High Momentum Sdn Bhd | LZA | Class I | |
| K070360 | Kirwan Disposable 23Khz Manifold Tubing, 40-3600, & 36Khz Manifold Tubing, 40-3601 | Kirwan Surgical Products, LLC | LFL | Unclassified | |
| K072057 | Osteograf/ld-300 | Dentsply International, Inc. | LYC | Class II | |
| K072056 | Osteograf/d-700 | Dentsply International, Inc. | LYC | Class II | |
| K071989 | Quill Self-Retaining System (Srs) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | NEW | Class II | |
| K071828 | Lullaby | GE Healthcare Clinical Systems | LBI | Class II | |
| K071807 | Orthomend Soft Tissue Matrix | Integra LifeSciences Braintree Inc. | FTM | Class II | |
| K071685 | Powder-Free Vinyl Patient Examination Gloves | Langfang Huilong Plastic Product Co., Ltd. | LYZ | Class I | |
| K071519 | Hemcon Chitoflex-Surgical Dressing | Hemcon, Inc. | QSY | Unclassified | |
| K071505 | Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring System | Integra LifeSciences Corporation | GWM | Class II | |
| K071435 | Nuvasive Oct System | NuVasive Inc | MNI | Class II | |
| K071377 | Polaris Be Rods | Highridge Medical, LLC | KWP | Class II | |
| K070938 | Thrombi-Paste Thrombin/gelatin Powder Paste Hemostat | Vascular Solutions LLC | QSX | Unclassified | |
| K070117 | Ssafe Plus Disposable Safety Syringe, 3 Cc and 5 Cc | Dolomite Biotech Sdn Bhd | MEG | Class II | |
| K063620 | Ekos Micro-Infusion System | Ekos Corp. | QEY | Class II | |
| K062854 | Benz-G 4X Hioxifilcon D | Benz Research and Development LLC | LPL | Class II | |
| K071767 | Dimensions Pbnp Flex Reagent Cartridge, Model Rf423a | Siemens Healthcare Diagnostics Inc. | NBC | Class II | |
| K072058 | Modification to: Osteograf/n-700 | Dentsply Interntional | LYC | Class II | |
| K072040 | C-Jaws Cervical Compressive Mini Frame | Medicrea Technologies | KWQ | Class II | |
| K072028 | Quill Self-Retaining System (Srs) Comprised of Monoderm | Surgical Specialties Corp | GAM | Class II | |
| K071996 | Mylab30, Model 7300 | Esaote S.p.A. | IYO | Class II | |
| K071960 | Meditech Ambulatory Blood Pressure Monitor, Model Abpm-05 | Meditech Kft. | DXN | Class II | |
| K071793 | Convertible I-Series Positioning and Transfer Chair | Barton Medical Corp. | INO | Class II | |
| K071761 | Lloyd Linden, Model E04 | Lloyd Linden, Inc. | IPL | Class II | |
| K071637 | Intrinsic Therapeutics Fixation Staple | Intrinsic Therapeutics Incorporated | JDR | Class II | |
| K071464 | Inion Hexalon Biodegradable Acl/pcl Screw | Inion Oy | HWC | Class II | |
| K071392 | Pxs-810, Podiatry X-Ray System | Source-Ray, Inc. | KPR | Class II | |
| K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | DZE | Class II | |
| K071341 | Modification to Arctic Sun Temperature Management System, Model 2000 | Medivance Inc. | DWJ | Class II | |
| K071281 | Uniring - Annuloplasty Ring with Sizers | Peters Surgical | KRH | Class II | |
| K071176 | Modification to: Arthrex Interference Screw | Arthrex GmbH | MAI | Class II | |
| K070727 | Advia Chemistry Enzymatic Creatinine_2 | Siemens Healthcare Diagnostics Inc. | JFY | Class II | |
| K070272 | Neuroport Electrode | Cyberkinetics Neurotechnology Systems, Inc. | GZL | Class II | |
| K070163 | Swabbable Cap, Model 60205 | Baxa Corp. | ODI | Class II | |
| K063835 | Allevyn Ag Dressing | Smith & Nephew, Inc. | FRO | Unclassified | |
| K063066 | Axis-V Monochrome 5 Mp Display | National Display Systems | LLZ | Class II | |
| K071903 | Endosheath Systems for Use with Vision-Sciences Tne Scope | Cogentix Medical, Inc. | EOX | Class II | |
| K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with Syringe | Abbott Medical | FMI | Class II | |
| K071771 | Instrumed Retractors | Instrumed International Inc dba Avalign German Specialty Instruments | GZT | Class II | |
| K071479 | Sbi Stafix | Small Bone Innovations, Inc. | JDR | Class II | |
| K071417 | Depuy Lps Diaphyseal and Metaphyseal Sleeves | Depuy Orthopaedics Inc. | MBH | Class II | |
| K071374 | Opus Twinlock Knotless Fixation Device | ArthroCare Corporation | MBI | Class II | |
| K071245 | Talon and Revere | Talon Acrylics, Inc. | EBI | Class II |