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 |
|---|---|---|---|---|---|
| K181539 | OSSDSIGN Cranioplug | Ossdsign | GXR | Class II | |
| K181220 | Juell 3D Volo Base | Park Dental Research Corp | EBI | Class II | |
| K180991 | AG 100s | Hospitech Respiration | BSK | Class II | |
| K180620 | Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC | DYB | Class II | |
| K180446 | b-ONE Total Knee System | b-ONE Ortho Corp. | JWH | Class II | |
| K180292 | PENTAX Video Upper G.I. Scope EG34-i10 | Pentax Medical of America, Inc. | FDS | Class II | |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group Ltd. | DCN | Class II | |
| K182826 | Ormco Spark Aligner System | Sybron Dental Specialties, Inc. | NXC | Class II | |
| K182244 | Voyant Electrosurgical Generator | Applied Medical Resources Corp | GEI | Class II | |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | CTL Medical Corporation | OVE | Class II | |
| K182015 | Piccolo Composite® Plate System | CarboFix Orthopedics Inc. | HRS | Class II | |
| K181617 | E-Cube 8 | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | Demetech Corp. | NBY | Class II | |
| K181520 | Sirona Dental CAD/CAM System | Dentsply Sirona Inc | NHA | Class II | |
| K181503 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | |
| K181460 | OnePacs System | Onepacs, LLC | LLZ | Class II | |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | Jiangsu Micsafe Medical Technology Co., Ltd | PNR | Class II | |
| K181330 | NeoMatriX Wound Matrix | Nextgen Biologics, Inc. | KGN | Unclassified | |
| K181091 | AxSOS 3 Ti | Stryker Corp. | HRS | Class II | |
| K181008 | NuFACE Trinity | Carol Cole Company dba NuFACE | NFO | Class II | |
| K180872 | Scarlet Srf | VIOL Co., Ltd. | GEI | Class II | |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray | Laclede, Inc. | LFD | Unclassified | |
| K180555 | Ergoline Prestige 1600 Hybrid Performance | Jk-Holding GmbH | LEJ | Class II | |
| K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | JEY | Class II | |
| K173920 | Ls Oil | J. Morita USA, Inc. | EKX | Class I | |
| K182531 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K182492 | Geminus Volar Distal Radius Plate System | Skeletal Dynamics, Inc | HRS | Class II | |
| K182289 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | DXT | Class II | |
| K182070 | BioHorizons Tapered IM Implants | BioHorizons Implant Systems Inc | DZE | Class II | |
| K181863 | Elvie Pump | Chiaro Technology Limited | HGX | Class II | |
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture | Teleflex Medical Incorporated | GAT | Class II | |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) | Cormatrix Cardiovascular, Inc. | PSQ | Class II | |
| K180468 | SBG Black Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | LZA | Class I | |
| K180467 | SBG Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | LZA | Class I | |
| K173194 | Temperature Probe | Orantech Inc. | FLL | Class II | |
| K172826 | Cellent Spinal Systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | NKB | Class II | |
| K182490 | Swiss LithoClast Trilogy | E.M.S. - Electro Medical Systems SA | FEO | Class II | |
| K181892 | Ziostation2 | Ziosoft, Inc. | LLZ | Class II | |
| K181818 | Scarlet AL-T | Spineart SA | OVD | Class II | |
| K181517 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K182117 | Vinyl Patient Examination Gloves | Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. | LYZ | Class I | |
| K182018 | Bluetooth blood pressure monitor | Shenzhen Kingyield Technology Co., Ltd | DXN | Class II | |
| K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | GXY | Class II | |
| K181868 | SHINY RPL System | Ids, Ltd. | ONF | Class II | |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | MAX | Class II | |
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) | Avenu Medical, Inc. | PQK | Class II | |
| K181642 | B-Laser Atherectomy System | Eximo Medical Ltd | MCW | Class II | |
| K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System | K2M, Inc | NKG | Class II | |
| K181587 | ORTHOLOC SPS Shoulder Plating System | TORNIER Inc. | HRS | Class II | |
| K181531 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | MAX | Class II |