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 |
|---|---|---|---|---|---|
| K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | DZE | Class II | |
| K231225 | EConsole1 | DRTECH Corporation | LLZ | Class II | |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. | QYM | Class II | |
| K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Qingdao Kingon Medical Science and Technology Co.,Ltd | CAW | Class II | |
| K230199 | Byte Aligner System | Dentsply Sirona Inc | NXC | Class II | |
| K232903 | Legend X Platform | Pollogen Ltd | GEI | Class II | |
| K232878 | TransLoc 3D | Foundation Fusion Solutions, LLC (dba Cornerloc) | OUR | Class II | |
| K232151 | Dynamic TiBase | Talladium Espana, SL | NHA | Class II | |
| K232089 | SOZO Pro | Impedimed, Inc. | DSB | Class II | |
| K231899 | HAtetracell™-C Titanium Cervical IBF System | Innovasis, Inc | ODP | Class II | |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | MHX | Class II | |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd | FBN | Class II | |
| K223911 | Lumen 155-SF | Intricon Corporation | QDD | Class II | |
| K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | Thi Total Healthcare Innovation GmbH | FXY | Class II | |
| K232118 | ANDORATE® Valve Kit | GA Health Company Limited | ODC | Class II | |
| K232020 | Iontophoresis Electrodes | Top-rank Health Care Co.,Ltd. | EGJ | Class II | |
| K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | Hunan Endoso Life Technology Co., Ltd | GCJ | Class II | |
| K230570 | Willow Generation 3 Breast Pump | Willow Innovations Inc. | HGX | Class II | |
| K230249 | Ikshana | ImmersiveTouch, Inc. | LLZ | Class II | |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | Anthogyr | DZE | Class II | |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) | Gbs Commonwealth Co., Ltd. | ODP | Class II | |
| K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K232481 | RIGEL™ 3DR Anterior Cervical Corpectomy System | Mirus, LLC | PLR | Class II | |
| K232437 | Paragon 8F Balloon Guide Catheter | Wallaby Medical | DQY | Class II | |
| K232429 | Titan Dental Design | Clearadvance, LLC | PNN | Class II | |
| K231744 | VyLink™ Spinal Screw System | VY Spine, LLC | NKB | Class II | |
| K231672 | S1 | Medpark Co., Ltd. | NPM | Class II | |
| K231642 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | LLZ | Class II | |
| K231495 | The Evolve System with the Transform Applicator | Inmode Ltd. | GEI | Class II | |
| K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | LCX | Class II | |
| K230495 | Serena Sleep Night Guard | Meris Investment Group | MQC | Unclassified | |
| K230440 | Xpert® Xpress CoV-2 plus | Cepheid | QQX | Class II | |
| K230370 | SpotLight/SpotLight Duo (with DLIR option) | Arineta Ltd. | JAK | Class II | |
| K230125 | Neuroblade System | Clearmind Biomedical | GWG | Class II | |
| K223863 | BONHAWA Respiratory Humidifier | Telesair, Inc. | BTT | Class II | |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | BioHorizons Implant Systems Inc | DZE | Class II | |
| K222143 | Apis (R), Veris (Tm) | Sweetbio | FRO | Unclassified | |
| K211676 | Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC | LCJ | Unclassified | |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | MTJ | Unclassified | |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | DXF | Class II | |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28 | KTT | Class II | |
| K232809 | Cross Vascular RF Generator and Footswitch (optional accessory) | Cross Vascular, Inc. | GEI | Class II | |
| K232802 | TMINI™ Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K232448 | FREEPRINT® splintmaster | Detax GmbH | MQC | Unclassified | |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | OZT | Class II | |
| K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation | JXI | Class II | |
| K231574 | Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K231551 | Stethophone | Sparrow Acoustics Inc. | DQD | Class II | |
| K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, L.L.C. | OVD | Class II |