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 |
|---|---|---|---|---|---|
| K191582 | Cartesion Prime | Canon Medical Systems Corporation | KPS | Class II | |
| K191376 | Modular Power Standing System | Motion Concepts LP | IPL | Class II | |
| K191024 | xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology Inc | HQC | Class II | |
| K190970 | PROSTEP™ TBI™ (Tailors Bunion Implant) System | Wrightmedicaltechnologyinc | HWC | Class II | |
| K190428 | Elecsys Anti-HAV II | Roche Diagnostics GmbH | LOL | Class II | |
| K191494 | Facilis™ Spinal System | Baui Biotech Co., Ltd. | NKB | Class II | |
| K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K191009 | Arsenal Plating System | Trilliant Surgical LLC | HRS | Class II | |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4WEB Inc. | OVE | Class II | |
| K190491 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | NHA | Class II | |
| K190025 | EVOL® -SI Joint Fusion System | Cutting Edge Spine | OUR | Class II | |
| K183316 | Dr J Spinal and Epidural Needles | Dr. Japan Co., Ltd. | BSP | Class II | |
| K183182 | Critical Care Suite | GE Healthcare | QFM | Class II | |
| K191884 | DR 100s | Agfa N.V. | IZL | Class II | |
| K191798 | Versana Active | GE Healthcare | IYN | Class II | |
| K191792 | Versana Balance | GE Healthcare | IYN | Class II | |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | Vascular Solutions LLC | DQY | Class II | |
| K191233 | Arietta 750 | FUJIFILM Healthcare Americas Corporation | IYN | Class II | |
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | Avenu Medical, Inc. | PQK | Class II | |
| K190371 | Morpheus-C | Biogennix, LLC | MQV | Class II | |
| K183647 | SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | |
| K183203 | ELAN 4 Tools | Aesculap Inc | HBE | Class II | |
| K183158 | NxStage Cartridge Express with Speedswap | NxStage Medical Inc | KDI | Class II | |
| K182881 | Bone Screw, Bone Tack | OSSTEM Implant Co., Ltd. | DZL | Class II | |
| K191575 | ARx Spinal System | Life Spine | NKB | Class II | |
| K191352 | binx health io CT/NG Assay | Binx Health, Inc. | QEP | Class II | |
| K191257 | Erchonia EVRL | Erchonia Corporation | NHN | Class II | |
| K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead | Medtronic, Inc. | LDF | Class II | |
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan | LPN | Class II | |
| K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System | In2bones USA, LLC | HRS | Class II | |
| K183312 | Conformity Stem | United Orthopedic Corp. | LZO | Class II | |
| K181760 | Transit-Pellets | Medifactia AB | FFX | Class II | |
| K191871 | 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | |
| K191841 | Accurate Multi Panel Drug Urine Test Cup | Healstone Biotech Inc. | NFT | Class II | |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. | PPN | Class II | |
| K191606 | RenovoCath | RenovoRx, Inc. | MJN | Class II | |
| K191394 | ILLUMISITE Platform | Medtronic, Inc. | JAK | Class II | |
| K191274 | BonAlive Granules | Bonalive Biomaterials, Ltd. | MQV | Class II | |
| K191012 | Navigated Pedicle Access Kit | Izi Medical Products LLC | OLO | Class II | |
| K190893 | Non-invasive Hemodynamic Blood Pressure Monitor | Vita-Course Technologies Co., Ltd. | DXN | Class II | |
| K190885 | Elevation Spine Saber-C System | Elevation Spine | OVE | Class II | |
| K190650 | Revolution Centrifugal Blood Pump | Corcym Inc. | KFM | Class II | |
| K183276 | 7D Surgical System | 7D Surgical, Inc. | HAW | Class II | |
| K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | Globus Medical, Inc. | NKB | Class II | |
| K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH | LZO | Class II | |
| K191565 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, LLC | OVE | Class II | |
| K191423 | Normandy VBR System | Zavation Medical Products, LLC | PLR | Class II | |
| K191295 | Percutaneous Introducer Needle | Progressive Medical Inc | GCJ | Class II | |
| K191158 | The AIO Solution | Orfit Industries NV | IYE | Class II |