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 |
|---|---|---|---|---|---|
| K043017 | Prevention Breathable, Impervious Surgical Gowns | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K042102 | Yixin Safety Syringe | Jiangxi Sanxin (Eversincere) Medical Devices Group | MEG | Class II | |
| K042051 | Arcomxl Polyethylene Liners | Zimmer GmbH | LPH | Class II | |
| K050276 | Diver C.e. Catheter | Invatec Innovative Technologies, S.r.l. | QEZ | Class II | |
| K050275 | Modification to: Inion Otps Biodegradable Pin | Inion Oy | HTY | Class II | |
| K050052 | Atlantis Abutment for Straumann Interface | Atlantis Components, Inc. | NHA | Class II | |
| K043578 | The 4Cis Spinal System and 4Cis Low Back System | Solco Biomedical Corp. | MNH | Class II | |
| K043433 | Autostat II Anti-Tissue Transglutaminase Igg Elisa | Hycor Biomedical | MVM | Class II | |
| K043195 | Neo Implant System | Neoss, Ltd. | DZE | Class II | |
| K043101 | Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions | Zimmer GmbH | JWH | Class II | |
| K042795 | Clever Chek Td-3213 | Taidoc Technology Corporation | NBW | Class II | |
| K050413 | Amplief Wrist Blood Pressure Monitor, Model M600 | Amplife Corporation | DXN | Class II | |
| K050403 | Spyglass Direct Visulation Probe | Boston Scientific Corporation | ODF | Class II | |
| K050338 | Modification to: Instaread Lithium System | Akers Biosciences, Inc. | JIH | Class II | |
| K050318 | Bari-Kad Packing Device | Bioenvelop Agro, Inc. | EIE | Class I | |
| K050247 | Contour Necklift Threads | Surgical Specialties Corp | GAW | Class II | |
| K050205 | Benephit Bifurcated Infusion Catheter and 5Fr. Introducer Sheath | Flowmedica, Inc. | KRA | Class II | |
| K050204 | Synthes Rapid Resorbable Tack System | Synthes (USA) Products LLC | JEY | Class II | |
| K050186 | Ameditech Immutest Multi-Drug Screen Panel III | Ameditech, Inc. | DKZ | Class II | |
| K050175 | Spacelabs Medical Multiparameter Module 91496 | GE Healthcare | DSI | Class II | |
| K050110 | Synthes (USA) Lcp Modular Foot Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K050048 | Hoffman II Micro External Fixation System | Howmedica Osteonics Corp | KTT | Class II | |
| K043591 | Featherlift Extended Aptos Thread | Kmi Kolster Methods, Inc. | GAW | Class II | |
| K043493 | Fusion Putty Type | GC America Inc. | ELW | Class II | |
| K043357 | Tosca 500 Pco2, Spo2 and Pulse Rate Monitoring System, Model 5202009 | Linde Medical Sensors AG | LKD | Class II | |
| K043331 | Digital Forehead Thermometer, Model Fs-100 | Hubdic Co., Ltd. | FLL | Class II | |
| K043223 | Depuy Cas Knee Instrumentation | Depuy Orthopaedics Inc. | HAW | Class II | |
| K043013 | Miltex Laparoscopic Instruments | Miltex, Inc. | HET | Class II | |
| K040202 | Salter Labs CPAP High Flow Cannula System | Salter Labs | BZD | Class II | |
| K024258 | Neurotech Kneehab | Bio-Medical Research, Ltd. | IPF | Class II | |
| K050162 | Contact EMG Rotatable Endotracheal Tube | Medtronic Xomed, Inc. | ETN | Class II | |
| K050144 | Prismatik Ceramic | Glidewell Laboratories | EIH | Class II | |
| K043581 | Dual Lumen Catheter | Acmi Corporation | EYB | Class II | |
| K043486 | Pascal Photocoagulator, Product-Pascal-01 | Iridex Corporation | GEX | Class II | |
| K043288 | Modification to Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | NAY | Class II | |
| K043217 | A&d Medical Ua-767Pbt Digital Blood Pressure Monitor | A and D Engineering, Inc. | DXN | Class II | |
| K041565 | Lazrpulsr 4X | Led Healing Light, LLC | NHN | Class II | |
| K050227 | Threvo Suture Anchor with Disposable Driver | Linvatec Corporation | MBI | Class II | |
| K043180 | Stryker Spine Trio Ps | Howmedica Osteonics Corp | MNH | Class II | |
| K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor | Ceremed, Inc. | KKY | Class II | |
| K042373 | Galeo Focus Guide Wire | BIOTRONIK AG | DQX | Class II | |
| K041999 | Gyrus Plasma Skin Resurfacing System | Gyrus ACMI, Inc. | GEI | Class II | |
| K041374 | Akonya Eliminator Mechanical Thrombectomy Device, Model El10060060 | Idev Technologies, Inc. | QEW | Class II | |
| K050360 | Tulip Condom | Shanghai Latex Factory | HIS | Class II | |
| K050297 | Somatom Emotion 16 | Siemens Medical Solution, Inc. USA | JAK | Class II | |
| K050142 | Resmed Meridian Mask | ResMed Corp | BZD | Class II | |
| K050066 | C-CO2 Colorimetric CO2 Indicator | Marquest Medical Products, Inc. | CCK | Class II | |
| K043513 | Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheter | Sterilmed Inc | NLH | Class II | |
| K043453 | Sterilemed Reprocessed Ivus Imaging Catheter | Sterilmed Inc | OWQ | Class II | |
| K043398 | Modification to Vascupuncture Picc Guidewire | Neometrics, Inc. | DQX | Class II |