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 |
|---|---|---|---|---|---|
| K191171 | EchoGo Core | Ultromics, Ltd. | QIH | Class II | |
| K192968 | Identify | Varian Medical Systems, Inc. | IYE | Class II | |
| K192932 | FDR D-EVO III flat panel detector system | FUJIFILM Corporation | MQB | Class II | |
| K192331 | LaseMD LEO Laser System | Lutronic Global | GEX | Class II | |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex | DSP | Class II | |
| K192202 | Clear21 | World Class Technology Corporation | NJM | Class II | |
| K191972 | ARIX Wrist System | Jeil Medical Corporation | HRS | Class II | |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics Inc | PCH | Class II | |
| K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) | PENTAX of America, Inc. | FDS | Class II | |
| K192661 | LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) | NHB | Class II | |
| K191986 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K190958 | Neodent Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K190661 | Omics Core | Nanthealth, Inc. | PZM | Class II | |
| K192819 | OEC Elite | GE Healthcare | OXO | Class II | |
| K192432 | IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 | Shenzhen Bosidin Technology Co., Ltd. | OHT | Class II | |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | BONWRx Ltd | NDN | Class II | |
| K192297 | APTUS Wrist Arthrodesis Plates | Medartis AG | HRS | Class II | |
| K192264 | HIVOX Spopad EMS SP-911, SP-921 | Hivox Biotek Inc. | NGX | Class II | |
| K192232 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K192118 | CRP Vario | Sentinel CH SpA | DCK | Class II | |
| K192049 | Oryx Cervical Plate System | Innovasis, Inc | KWQ | Class II | |
| K192019 | Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 | Abbott Medical | DQO | Class II | |
| K191959 | QuantX Breast MRI Biopsy Guidance Plugin | Qlarity Imaging | LLZ | Class II | |
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co KG | EMA | Class II | |
| K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | |
| K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | PENTAX of America, Inc. | PEA | Class II | |
| K191237 | CERENOVUS Large Bore Catheter | Cerenovus, Inc. | DQY | Class II | |
| K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | O&M Halyard, Inc. | LZC | Class I | |
| K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | EBC | Class II | |
| K182301 | PFC SIGMA Knee System | Depuy Orthopaedics Inc. | JWH | Class II | |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | Bard Peripheral Vascular Inc | KNW | Class II | |
| K192891 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | GCJ | Class II | |
| K192871 | B. anthracis Real-time PCR Assay | Centers for Disease Control and Prevention | NHT | Class II | |
| K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless | Canon, Inc. | MQB | Class II | |
| K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | Synthes (USA) Products LLC | HRS | Class II | |
| K192181 | PRECICE Plating System | NuVasive Specialized Orthopedics, Inc. | KTT | Class II | |
| K192153 | Portux CAD/CAM Disc | New Stetic | EBG | Class II | |
| K191564 | Progenikine Concentrating System 25 mL System | EmCyte Corporation | MUU | Class II | |
| K191466 | SandShark Injectable Anchor (SIA) System | Curonix LLC | GZB | Class II | |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corp. | NEW | Class II | |
| K191026 | Medip Pro | MEDICAL IP Co., Ltd. | LLZ | Class II | |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | PIF | Class II | |
| K190872 | BioGenesis Fertility Lubricant | Good Clean Love, Inc. | PEB | Class II | |
| K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | ELW | Class II | |
| K192729 | Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml | Thermo Fisher Scientific Oy | JWY | Class II | |
| K192198 | Conformis Hip System | ConforMIS, Inc. | LPH | Class II | |
| K191918 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific Oy | LRG | Class II | |
| K191914 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific Oy | LRG | Class II | |
| K191891 | SOMATOM X.cite | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K191651 | Arthrex Nano SwiveLock Suture Anchor | Arthrex GmbH | HWC | Class II |