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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K900980 | Latex Examination Gloves | Sinochem (USA), Inc. | LYY | Class I | |
| K900488 | Modified X-Ring and Speed Stix Plastice Ligature | American Orthodontics | EJF | Class I | |
| K896998 | Atrauclip (Tantalum Hemostatic Clip) | S.P.K. Technology, Inc. | MCH | Class II | |
| K896779 | CT-1000A System | Bio-Monitor, Inc. | FLL | Class II | |
| K902146 | Sfd-035 Spot Film Device | Rms Div. | IXL | Class II | |
| K901988 | Document(r) Reflectance I Linearity Test Set | Casco Standards | JJY | Class I | |
| K901986 | Co-Oximeter Controls | Phoenix Diagnostics, Inc. | JJS | Class I | |
| K901976 | Blood Gas/co-Oximetry Control | Phoenix Diagnostics, Inc. | JJS | Class I | |
| K901964 | Phosphorus Reagents Prod Codes 7763/7764/7563/7463 | American Research Products Co. | CEO | Class I | |
| K901960 | Iron Reagents Product Codes 7725 and 7726 | American Research Products Co. | JMO | Class I | |
| K901939 | Neocoat T4 | Neometrics, Inc. | CDX | Class II | |
| K901864 | Model 4050-21; 5.25 Loop Shoulder Coil | Medical Advances, Inc. | LNH | Class II | |
| K901748 | Kestrel Lens Case (208-12Nt Polystyrene) | Kestrel | LRX | Class II | |
| K901618 | Ocular Infusion Cannula System | Tamcenan Corp. | HMX | Class I | |
| K901567 | The Huestis Compu-Plotter | Huestis Machine Corp. | IXI | Class II | |
| K901301 | Ster Inhal Solut Prefil Btl W/adjust Entrain Nebul | Automatic Liquid Packaging, Inc. | CAF | Class II | |
| K901216 | Enzymun Test(r) Digoxin | Boehringer Mannheim Corp. | KXT | Class II | |
| K900200 | Cook Stereotaxic Guide | Cook, Inc. | HAW | Class II | |
| K900178 | Electric Motor W/physio Dispenser, Handpieces | Core-Vent Corp. | EFS | Class I | |
| K900096 | Intelligent Visual Reinforcement Audiometry (Ivra) | Artifical Hearing Systems Corp. | EWO | Class II | |
| K897195 | A-Company Electrothermal Debonding Device (Etd) | A Company, Inc. | EKS | Class I | |
| K896554 | Gut Sutures | Look, Inc. | GAL | Class II | |
| K901875 | Para 12 Plus | Streck Laboratories, Inc. | JCN | Class II | |
| K901771 | Siemens Sirecust 732, Patient Monitor | Siemens Medical Electronics | DPS | Class II | |
| K901749 | Taba Patient Examination Gloves | R.S.T. Corp. | LYY | Class I | |
| K901268 | Coulter Albumin Reagent | Coulter Corp. | CIX | Class II | |
| K901018 | Modified Transluminal Balloon Dilatation Catheters | Boston Scientific Corporation | LIT | Class II | |
| K901009 | Model 2000 Intraoperative Corneascope | Kera Corp. | HLQ | Class I | |
| K900719 | Rotag Controls | Roche Diagnostic Systems, Inc. | JJX | Class I | |
| K900416 | Hand Controls, Model 3700 and 3500 Series | Mobility Products & Design | IPQ | ||
| K900373 | Biotrack Theophylline Test Cartridge | Biotrack, Inc. | KLS | Class II | |
| K902206 | Control 1 Environmental Control | Prentke Romich Co. | ILQ | Class II | |
| K901943 | Ktp/532 (Tm) Surgical Laser | Laserscope | GEX | Class II | |
| K901783 | Audiotone Ite Hearing Aid Model Za (Micro) | Miracle-Ear, Inc. | ESD | Class I | |
| K901747 | Audiotone Ite Hearing Aid Model Zg (Mirage) | Miracle-Ear, Inc. | ESD | Class I | |
| K901746 | Audiotone Ite Hearing Aid Model Zd (Xt) | Miracle-Ear, Inc. | ESD | Class I | |
| K901745 | Audiotone Model a-52S Behind-the-Ear Hearing Inst. | Miracle-Ear, Inc. | ESD | Class I | |
| K901679 | Resubmitted Isg 3Dmv Workstation | I.S.G. Technologies, Inc. | LLZ | Class II | |
| K901617 | Endoscopic Carpal Tunnel Release System (Ectr) | Smith & Nephew, Inc. | HRX | Class II | |
| K901376 | Mayflower Brand Patient Examination Gloves | Kai FU Trading Co. | LYY | Class I | |
| K901326 | Challenge 20 Powered Muscle Stimulator | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | |
| K901098 | Spartan Plus | Ivoclar North America, Inc. | EJT | Class II | |
| K901077 | Prelude (Temporary Crown and Bridge Cement) | Scientific Pharmaceuticals, Inc. | EBG | Class II | |
| K901049 | Copal Varnish | Pulpdent Corporation | LBH | Class II | |
| K900575 | Ultra-Trac | Practical Healthcare Devices, Inc. | ITH | Class II | |
| K896848 | Lift Master Patient Lift | Henry Enterprises, Inc. | FNG | Class II | |
| K901380 | Cascade 480(Tm) Automated Coagulation Analy. 1430 | Helena Laboratories, Corp. | GKP | Class II | |
| K901363 | Topographic Modeling System | Computed Anatomy, Inc. | HLQ | Class I | |
| K901327 | Ortho Correction Reagents | Ortho Diagnostic Systems, Inc. | GJT | Class II | |
| K900946 | Universum | Scientific Pharmaceuticals, Inc. | LBH | Class II |