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 |
|---|---|---|---|---|---|
| K183682 | OIC External Fixation System | The Orthopaedic Implant Company | KTT | Class II | |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | Scandidos, Inc. | IYE | Class II | |
| K183550 | Vitality® Spinal Fixation System | Highridge Medical, LLC | NKB | Class II | |
| K183539 | Ergoline Sunrise 7200 Hybrid Technology | Jk-Holding GmbH | LEJ | Class II | |
| K183496 | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K183204 | Bone VCAR (BVCAR) | GE Medical Systems SCS | JAK | Class II | |
| K182375 | CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® | Globus Medical, Inc. | NKB | Class II | |
| K182287 | MEDINAUT Plus | Imedicom Co., Ltd. | HRX | Class II | |
| K190598 | CROSSWAY Spinal Access System | Globus Medical, Inc. | HRX | Class II | |
| K190581 | Amplatzer Trevisio Intravascular Delivery System | Abbott Medical | DQY | Class II | |
| K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | |
| K190038 | Xbody Newave USA | Xbody Hungary Kft. | NGX | Class II | |
| K183494 | R190/R191 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | QEY | Class II | |
| K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Kossan International Sdn Bhd | LZA | Class I | |
| K182268 | EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) | Flat Medical Co., Ltd. | FMF | Class II | |
| K182175 | Tcd-X | Atys | IYN | Class II | |
| K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd | MWI | Class II | |
| K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare, Inc. | CBP | Class II | |
| K190691 | Pixx2430 Digital Diagnostic X-Ray Receptor Panel | PixxGen Corporation | MQB | Class II | |
| K190416 | Dome Electrode | Coapt LLC | GXY | Class II | |
| K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | Olympus Surgical Technologies America | ODC | Class II | |
| K183445 | Erbe APCapplicators | ERBE Elektromedizin GmbH | GEI | Class II | |
| K183377 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K183304 | Prettau, ICE, Z-White zirconia blanks | Zirkonzahn SRL | EIH | Class II | |
| K183197 | PYRAMESH™ Implant System | Medtronic Sofamor Danek USA Inc | MQP | Class II | |
| K182943 | VERTEX Nitinol Staple System | Nvision Biomedical Technologies, Inc | JDR | Class II | |
| K182399 | Park Blade Septostomy Catheter | Cook Incorporated | DXF | Class II | |
| K182253 | FUJIFILM Video Bronchoscopes | FUJIFILM Corporation | EOQ | Class II | |
| K181931 | GMC Upper Arm Automatic Blood Pressure Monitor | Gmc, Inc. | DXN | Class II | |
| K180843 | HIgH-Flo Super26 Subcutaneous Needle Sets | Repro-Med Systems, Inc. dba Rms Medical Products | FPA | Class II | |
| K173238 | ToxCO | Bedfont Scientific Ltd. | CCJ | Class II | |
| K190586 | Monster® Screw System | Paragon 28 | HWC | Class II | |
| K190557 | Bio-Medicus Insertion Kit | Medtronic, Inc. | DWF | Class II | |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | CGA | Class II | |
| K190289 | Karma® Fixation System | Spinal Elements, Inc | OWI | Class II | |
| K190230 | iFuse Implant System® | SI-Bone, Inc. | OUR | Class II | |
| K183376 | HORIZON TMS Therapy System with Navigation | Magstim Inc. | OBP | Class II | |
| K183184 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | |
| K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | JWH | Class II | |
| K182597 | Infrared thermometer | Shenzhen Pango Electronic Co., Ltd. | FLL | Class II | |
| K182349 | Concorde Lift | Medos International SARL | MAX | Class II | |
| K180232 | DAEHAN Disposable CUP Electrodes | Daehan Medical Systems Co.,Ltd | GXY | Class II | |
| K190248 | Arietta 50 | FUJIFILM Healthcare Americas Corporation | IYN | Class II | |
| K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | NQQ | Class II | |
| K182836 | FUJIFILM Endoscope Model EG-740N | FUJIFILM Corporation | FDS | Class II | |
| K181171 | Zimmer Biomet Ceramic Heads | Zimmer GmbH | LZO | Class II | |
| K190629 | DBSWIN and VISTAEASY Imaging Software | Durr Dental SE | LLZ | Class II | |
| K190447 | 7400 Ultrasound Systems | Navigant Consulting - on Behalf of Esaote S.p.A. | IYN | Class II |