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 |
|---|---|---|---|---|---|
| K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde | Modern Medical Equipment Manufacturing Ltd. | GEI | Class II | |
| K190408 | Spinal Fixation System | Shangdong Kangsheng Medical Devices Co., Ltd. | NKB | Class II | |
| K201481 | Centurion POCT System | Orthofix SRL | NKG | Class II | |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) | Boston Scientific Corporation | FTM | Class II | |
| K201116 | Abiomed 23 Fr Sheath | Abiomed, Inc. | DYB | Class II | |
| K200899 | Quantib AI Node | Quantib B.V. | LLZ | Class II | |
| K200508 | Pump In Style | Medela AG | HGX | Class II | |
| K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | OVE | Class II | |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec Inc | HQC | Class II | |
| DEN200026 | EndeavorRx | Akili Interactive Labs, Inc. | QFT | Class II | |
| K200446 | STERIS Patient Warming System | STERIS Corporation | DWJ | Class II | |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Co., Inc. | DRE | Class II | |
| K201022 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | OLO | Class II | |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM) | Ekf Diagnostic GmbH | GKR | Class II | |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | MWP | Class II | |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir | Corcym Inc. | DTZ | Class II | |
| K200521 | Full Automatic(NIBP) Blood Pressure Monitor | Health & Life Corporation | DXN | Class II | |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | Edwards Lifesciences LLC | DXE | Class II | |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Medical | QLG | Class II | |
| K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | MUE | Class II | |
| K192201 | Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. | NUH | Class II | |
| K201271 | Benchmark BMX96 Access System | Penumbra Inc. | DQY | Class II | |
| K201117 | Gold Anchor | Naslund Medical Inc. | IYE | Class II | |
| K201007 | In-Ka Ureteral Balloon Dilatation Catheter | MEDLINE INDUSTRIES, LP - Northfield | EZN | Class II | |
| K200998 | Versana Active | GE Healthcare | IYN | Class II | |
| K200980 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | IYO | Class II | |
| K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | Mirus, LLC | ODP | Class II | |
| K200616 | E>EyeC | E-Swin | ONF | Class II | |
| K200356 | Medo Aria | Medo.Ai | QIH | Class II | |
| K193415 | physIQ Heart Rhythm and Respiration Module | Physiq, Inc. | DPS | Class II | |
| K192630 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K201255 | TSolution® One Total Knee Application | Think Surgical Inc. | OLO | Class II | |
| K201247 | Intraoral Sensor | Dentium Co.,Ltd(ict Branch) | MQB | Class II | |
| K200976 | SR-8230, SR-8230S Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IZL | Class II | |
| K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical Inc. | QAU | Class II | |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K200487 | RayCare 3.1 | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K200131 | BruxZir Steel | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K193094 | Naviswiss Hip Navigation System | Naviswiss AG | OLO | Class II | |
| K192003 | Auxein Nailing System | Auxein medical Private Limited | JDS | Class II | |
| K201063 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | GEI | Class II | |
| K200786 | Venus Epileve | Venus Concept USA Inc. | GEX | Class II | |
| K200753 | IBS Implant System II | Innobiosurg Co., Ltd. | NHA | Class II | |
| K200042 | CO2 Laser System | Beijing Superlaser Technology Co., Ltd. | GEX | Class II | |
| K193075 | Osteo3 ZP Putty | Sirakoss, Ltd. | MQV | Class II | |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip | Bennett Jacoby, Dds, Ms, Inc. | DZI | Class II | |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | ImmersiveTouch, Inc. | DZJ | Class II | |
| K200015 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | IRP | Class II | |
| K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System | Wrightmedicaltechnologyinc | HSN | Class II |