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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K153181 | Maia | Centervue | MYC | Class II | |
| K152597 | ProteXsure Safety Capsule System | Starcap Medical, LLC ( dba Prism Medical & Design) | FMI | Class II | |
| DEN130051 | Pediatric Vision Scanner | Rebiscan, Inc. | PMW | Class II | |
| K161297 | Beta-2-Microglobulin | Beckman Coulter Ireland Inc | JZG | Class II | |
| K161147 | EndoCure Model EUR078A | Endocure Technologies, Inc. | FBN | Class II | |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | Kensey Nash Corporation dba Dsm Biomedical | NPL | Class II | |
| K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | PEM | Class II | |
| K160005 | Contact Lens Case (multiple brand name) | Danyang Chanxin Glasses Cases Factory | LRX | Class II | |
| K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | LHC | Class I | |
| K153388 | IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle | Guangzhou Improve Medical Instruments Co., Ltd. | FMI | Class II | |
| K152877 | SureFine Pen Needle | Shina Med Corporation | FMI | Class II | |
| K152786 | A Plus Internal Fixture System | T-Plus Implant Tech. Co., Ltd. | DZE | Class II | |
| K151250 | Smart Set | Top Spins, Inc. | FPA | Class II | |
| K151137 | X-View, Imagen | Edlen Imaging, LLC | OAS | Class II | |
| K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | ELL | Class II | |
| K153436 | LATERAL Spine Truss System | 4WEB Inc. | MAX | Class II | |
| K152729 | Microperimeter Mp-3 | Nidek Co., Ltd. | HKI | Class II | |
| K151239 | Nmi Dual Port II | Boston Scientific Corporation | LJT | Class II | |
| K142130 | Oral Bond | Steiner Laboratories | EMA | Class II | |
| K161183 | Halo One Thin-Walled Guiding Sheath | C.R. Bard Inc | DYB | Class II | |
| K160905 | Sonendo GentleWave System | Sonendo Inc | ELC | Class II | |
| K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | NKB | Class II | |
| K160668 | HumaPen Savvio | Eli Lilly and Company, Pharmaceutical Delivery Systems | FMF | Class II | |
| K160655 | OrthoButton CL | Riverpoint Medical, LLC | MBI | Class II | |
| K160652 | iFUSE Implant System | SI-Bone, Inc. | OUR | Class II | |
| K160617 | Large Screws Range | Newclip Technics | HWC | Class II | |
| K160427 | dynaMX(TM) Nitinol Compression Screw | Mx Orthopedics, Corp. | HWC | Class II | |
| K160115 | Heat Pain Pro | Omron Healthcare Co., Ltd. | NUH | Class II | |
| K153719 | LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream | Honeywell Hommed, LLC | DRG | Class II | |
| K153704 | Strive | DJO, LLC | GZJ | Class II | |
| K153611 | Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device | Ethicon, Inc | GAM | Class II | |
| K153518 | Medipure Oxygen-LC System | Praxair Distribution, Incorporated. | ECX | Class I | |
| K153164 | LunulaLaser | Erchonia Medical, Inc. | PDZ | Class II | |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner | Signature Orthopaedics Pty Limited | MEH | Class II | |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes | Bio Protech, Inc. | IKT | Class II | |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test Kit | Maine Standards Co. | GGN | Class II | |
| K152893 | Corin Optimized Positioning System (OPS) | Corin USA | LZO | Class II | |
| K152561 | Communicator Surgical Facemask with Clear Window | Prestige Ameritech | FXX | Class II | |
| K152521 | Seal Rite Non-Rebreathing Valve | The Lifeguard Store, Inc. | CBP | Class II | |
| K152301 | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated | OMA | Class II | |
| K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | BZH | Class II | |
| DEN150040 | WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific Corporation | PNB | Class II | |
| K161193 | 16ch Tx/Rx Knee SPEEDER | Quality Electrodynamics | MOS | Class II | |
| K160244 | VARIOunite | Thommen Medical AG | NHA | Class II | |
| K160119 | NobelSpeedy Groovy | Nobel Biocare AB | DZE | Class II | |
| K160099 | CEREC SpeedGlaze | Sirona Dental Systems GmbH | EIH | Class II | |
| K160012 | O-pel Laser and families of probe delivery devices | Precise Light Surgical | GEX | Class II | |
| K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application | Smith & Nephew, Inc. | GCJ | Class II | |
| K153280 | PowerGlide Pro Midline Catheter | C.R. Bard Inc | FOZ | Class II | |
| K153036 | NobelDesign Software | Nobel Biocare AB | NHA | Class II |