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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K203735 | Brainsway Deep TMS System | Brainsway Ltd. | OBP | Class II | |
| K203605 | SteriTrak | Arbutus Medical, Inc | JEC | Class II | |
| K203502 | MEDO-Thyroid | Medo DX Pte., Ltd. | QIH | Class II | |
| K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | Canon Medical Systems Corporation | KPS | Class II | |
| K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical | HGI | Class II | |
| K202607 | Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs | String King Lacrosse, LLC | FXX | Class II | |
| K202462 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | FRG | Class II | |
| K202387 | Disposable Surgical Face Mask | Guangdong Bida Medical Technology Co., Ltd. | FXX | Class II | |
| K202257 | Dermatological Diode Laser Systems | Zhuolu Jontelaser Manufacturing Technology Co., Ltd. | GEX | Class II | |
| K202043 | Secret Duo | Ilooda Co,., Ltd. | GEX | Class II | |
| K201853 | Naton Disposable Surgical Face Mask | Naton Biotechnology (Beijing) Co., Ltd. | FXX | Class II | |
| K192190 | Solax Electric Scooter | Dongguan Prestige Sporting Goods Co., Ltd. | INI | Class II | |
| DEN200046 | Neurolutions Upper Extremity Rehabilitation System | Neurolutions | QOL | Class II | |
| K210893 | Restoration Anatomic Shell | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | |
| K210549 | ARx Spinal System | Life Spine | NKB | Class II | |
| K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | LXC | Unclassified | |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | MEDLINE INDUSTRIES, LP - Northfield | JDR | Class II | |
| K210065 | Verifine Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K203646 | Disposable Medical Face Mask | Guangzhou Mei YI Kang Medical Technology Co., Ltd. | FXX | Class II | |
| K203570 | Mya Joy PLUS Breast Pump | Ameda, Inc. | HGX | Class II | |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | |
| K203353 | Dvt-Pro | Daesung Maref Co.,Ltd | JOW | Class II | |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | Parker Hannifin Corp. | BZR | Class II | |
| K200329 | IDCAM Dental Implants | Implants Diffusion International | DZE | Class II | |
| K210988 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | MQB | Class II | |
| K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | United Orthopedic Corp. | JWH | Class II | |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.r.l. | PBX | Class II | |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | FDF | Class II | |
| K210580 | InnovaMatrix FS | Triad Life Sciences, Inc. | KGN | Unclassified | |
| K210556 | Preview Shoulder | Genesis Software Innovations | QIH | Class II | |
| K210483 | MOBIO Total Knee System | b-ONE Ortho Corp. | JWH | Class II | |
| K210145 | Nitrile Glove Powder Free Blue | Changzhou Universal Medical Equipment Co., Ltd. | LZA | Class I | |
| K203533 | Vassallo Gt | Filmecc Co., Ltd. | DQX | Class II | |
| K202759 | Disposable medical surgical mask | Chongqing Coe Display Technology Co., Ltd. | FXX | Class II | |
| K202750 | Knee+ | Pixee Medical | SBF | Class II | |
| K202639 | si-Mochi | Biostone Co. Ltd. | MQV | Class II | |
| K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | PDU | Class II | |
| K210835 | Identify | Varian Medical Systems, Inc. | IYE | Class II | |
| K210427 | M.U.S.T. Midline Cortical (MC) Screw System | Medacta International SA | NKB | Class II | |
| K210157 | SOLE Medial Column Fusion Plate | Orthofix SRL | HRS | Class II | |
| K203805 | Disposable Nitrile Examination Gloves | Jiangsu Yanfang Medical Technology Co., Ltd. | LZA | Class I | |
| K203610 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | QKB | Class II | |
| K203596 | Panthera Occlusal Appliance | Panthera Dental Inc | MQC | Unclassified | |
| K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | LCM | Unclassified | |
| K203276 | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | NOY | Class II | |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | Maquet Critical Care AB | CBK | Class II | |
| K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | NKB | Class II | |
| K210134 | Dentis s-Clean s-Line | Dentis Co.,Ltd | DZE | Class II | |
| K210121 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II | |
| K203824 | VPS Impression Material | Hygedent Inc. | ELW | Class II |