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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K233736 | LifeSPARC System | Cardiacassist, Inc. | QNR | Class II | |
| K233728 | SIGNA Champion | GE Healthcare (Tianjin) Company Limited | LNH | Class II | |
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | Hi-Dow International Inc. | NUH | Class II | |
| K233436 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical Inc. | QAD | Class II | |
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | EOX | Class II | |
| K232783 | Power wheelchair (Model: JMPW-01W) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | ITI | Class II | |
| K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister | Argon Medical Devices, Inc | QEW | Class II | |
| K232466 | Electric Breast Pump, model: YM-8166 | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | |
| K232347 | MagnetOs Granules | Kuros Biosciences BV | MQV | Class II | |
| K232156 | Rapid ASPECTS (v3) | Ischemaview, Inc. | POK | Class II | |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional | Depuy Ireland UC | MEH | Class II | |
| K231237 | BD Vacutainer® Fluoride Blood Collection Tubes | Becton Dickinson & Co | JKA | Class II | |
| K231218 | Distal Access Catheter | Accumedical Beijing, Ltd. | QJP | Class II | |
| K231213 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | HRS | Class II | |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | NBW | Class II | |
| K231071 | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K230817 | TORPEDO Implant System® | Deltacor GmbH | OUR | Class II | |
| K230524 | Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd | IRP | Class II | |
| K230133 | Plenity | Gelesis SRL | QFQ | Class II | |
| DEN220009 | VerTouch Spinal Imaging Device | Intuitap Medical, Inc | QXD | Class II | |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Spinal Simplicity, LLC | PEK | Class II | |
| K234040 | TriMed Threaded Intramedullary Nail System | Trimed Inc | HWC | Class II | |
| K234031 | Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, Inc. | HRS | Class II | |
| K234011 | AMF TT Cones | Lima Corporate S.p.A. | JWH | Class II | |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | MAX | Class II | |
| K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter | William Cook Europe ApS | DTK | Class II | |
| K233507 | EVOLUTION® Tibial Cones | Microport Orthopedics Inc. | MBH | Class II | |
| K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex GmbH | GCJ | Class II | |
| K233447 | CeQur Simplicity™ On-Demand Insulin Delivery System | CeQur SA | OPP | Class II | |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics Inc. | NQD | Class II | |
| K233213 | NxStage PureFlow Solution | NxStage Medical Inc | KPO | Class II | |
| K233190 | ENFit Adaptor | Jiangsu Caina Medical Co., Ltd | PIO | Class II | |
| K233077 | FlashHeal 2 (FlashHeal 2.0) | Inwound ApS | GEX | Class II | |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | PENTAX of America, Inc. | EOQ | Class II | |
| K232698 | NemoScan | Software Nemotec, S.L. | QIH | Class II | |
| K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | DXC | Class II | |
| K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | FTL | Class II | |
| K231860 | TDM Screw System | Tdm Co., Ltd. | HWC | Class II | |
| K231762 | uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K231573 | ThinkQA (Edition 2) | Dosisoft | IYE | Class II | |
| K231416 | Air Next (NVD-02) | Nuvoair AB | BZG | Class II | |
| K231405 | Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. | GEI | Class II | |
| K231166 | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | Zmi Electronics Ltd. | KPI | Class II | |
| K230592 | LuxCreo Dental Night Guard Resin | Luxcreo Inc. | MQC | Unclassified | |
| K221866 | S-Plant Dental Implant System | Newton Implant Systems | DZE | Class II | |
| K234030 | Clear Guide SCENERGY | Clear Guide Medical | JAK | Class II | |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | DSY | Class II | |
| K233730 | Footprint Mini PK, 3.5mm Suture Anchor | Smith & Nephew, Inc. | MBI | Class II | |
| K233710 | Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. | PGT | Class II |