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 |
|---|---|---|---|---|---|
| K180889 | Tractus Crossing Support Catheter | Tractus Vascular, LLC | DQY | Class II | |
| K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System | Signature Orthopaedics Pty Limited | NKB | Class II | |
| K180679 | CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) | Global Scientific Technologies, LLC | KPO | Class II | |
| K180670 | ICONN Campbell Interference Screw | Iconn Orthopedics, LLC | HWC | Class II | |
| K180657 | Resin for Temporary Crown & Bridge | Dentis Co.,Ltd | EBG | Class II | |
| K180175 | SignalMark Lung Biopsy Site Marker | View Point Medical, Inc. | GDW | Class II | |
| K172897 | Neck Care Therapy, Model: SYK 509B | Shenzhen Osto Technology Company Limited | NUH | Class II | |
| K183116 | Unity Network ID | GE Healthcare | MWI | Class II | |
| K183098 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K182926 | IntelliSpace Radiology | Philips North America LLC | LLZ | Class II | |
| K182680 | KerraContact Ag Perf Advanced Perforated Silver Wound Dressing | Exciton Technologies Inc. | FRO | Unclassified | |
| K182438 | Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA LLC | MOL | Class II | |
| K182373 | PowerLook Tomo Detection V2 Software | iCAD, Inc. | QDQ | Class II | |
| K182125 | EVOLUTION Stemmed CS Femur | Microport Orthopedics Inc. | JWH | Class II | |
| K182035 | FFRct | Heartflow, Inc. | PJA | Class II | |
| K182016 | Simplicit90Y | Mirada Medical Limited | LLZ | Class II | |
| K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | HIH | Class II | |
| K181958 | MagnetOs Putty | Kuros Biosciences BV | MQV | Class II | |
| K181727 | Vivid iq | GE Healthcare | IYN | Class II | |
| K181529 | Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection | Contego Medical, Inc | LIT | Class II | |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | MAX | Class II | |
| K181231 | DePuy Synthes T-PAL Spacer System | Depuy Synthes Spine | MAX | Class II | |
| K181107 | Elevo® Kit Snoring Intervention Device | Zelegent, Inc. | LRK | Class II | |
| K173749 | AMRA Profiler | Amra Medical AB | LNH | Class II | |
| K173048 | No-contact Forehead Thermometer | Dongguan Simzo Electronic Technology Co., Ltd. | FLL | Class II | |
| K163601 | RII Smart IR Thermometer | Radiant Innovation Inc. | FLL | Class II | |
| K183191 | 6420 Ultrasound System | Esaote S.p.A. | IYN | Class II | |
| K183069 | NobelZygoma 0° | Nobel Biocare AB | DZE | Class II | |
| K183065 | Coolrail Linear Pen | AtriCure, Inc. | OCL | Class II | |
| K183037 | Monaco RTP System | Elekta Limited | MUJ | Class II | |
| K183034 | MOSAIQ Oncology Information System | Elekta Limited | IYE | Class II | |
| K182949 | Healix™ Compression Screw System | Nvision Biomedical Technologies, Inc | HWC | Class II | |
| K182479 | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus | Hycor Biomedical | DHB | Class II | |
| K182076 | Elekta Unity | Elekta Limited | IYE | Class II | |
| K181970 | MectaLIF Posterior Extension | Medacta International SA | MAX | Class II | |
| K181935 | Endoform Reconstructive Template - Non Absorbable | AROA Biosurgery Inc. | FTL | Class II | |
| K181825 | CAAS MR Solutions | PIE Medical Imaging B.V. | LLZ | Class II | |
| K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K180653 | Spartan eCoil System | Spartan Micro, Inc. | HCG | Class II | |
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | Fresenius Kabi USA, LLC | LKN | Unclassified | |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | NFT | Class II | |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set | Sol-Millennium Medical, Inc. | FMI | Class II | |
| K181908 | Action Trackchair | Action Manufacturing, Inc. | ITI | Class II | |
| K181159 | LZI Fentanyl Enzyme Immunoassay | Lin-Zhi International Inc | DJG | Class II | |
| K173083 | Implanter Dental Planning Software | Implanter, LLC | LLZ | Class II | |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics Inc | PCH | Class II | |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics Inc | PCH | Class II | |
| K182815 | XVWeb 3D | Apteryx, Inc. | LLZ | Class II | |
| K182797 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL | Thermo Fisher Scientific Oy | JWY | Class II |