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 |
|---|---|---|---|---|---|
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | JWH | Class II | |
| K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | DQD | Class II | |
| K261644 | Perfadex Plus | Xvivo Perfusion, Inc. | KDN | Class II | |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system | Esonic Technology (Wuhan) Co., Ltd. | IYN | Class II | |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | DXN | Class II | |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corp. | DXN | Class II | |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co., Ltd | IYN | Class II | |
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni | QIH | Class II | |
| K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd | NFO | Class II | |
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | BZD | Class II | |
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | ODP | Class II | |
| K251576 | Total Flow Medical Femoral Arterial (TFA) cannula | Total Flow Medical Limited | SFF | ||
| K262211 | Lancet | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | |
| K262094 | E3D™-C Interbody System | Evolution Spine, LLC | OVE | Class II | |
| K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | DXC | Class II | |
| K262075 | Lapidus Screw Kit | Relja Innovations, Inc | HWC | Class II | |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | GEI | Class II | |
| K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | OLO | Class II | |
| K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | PSY | Class II | |
| K260804 | Anovo Surgical System (6Ne) | Momentis Surgical Ltd. | SCV | Class II | |
| K260721 | Tornier Perform Advanced Glenoid | TORNIER Inc. | KWS | Class II | |
| K254296 | Ossiclear (Ossiclear System) | Sounduct | LXB | Class II | |
| K253840 | STEDI Scan Device | Stroke DX | QAF | Class II | |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | LZA | Class I | |
| K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Xuzhou Kernel Medical Equipment Co Ltd | |||
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | |
| K261728 | One-Fil LC | Mediclus Co., Ltd | EJK | Class II | |
| K261406 | Versalock Proximal Tibial Plating System | GM dos Reis Industria e Comercio Ltda | HRS | Class II | |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | Hycor Biomedical | DHB | Class II | |
| K260500 | ResolutionMD | ResolutionMD, Inc. | LLZ | Class II | |
| K253814 | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development Co | HBO | Class II | |
| K253770 | CardIQ Suite | GE Medical Systems SCS | JAK | Class II | |
| DEN250068 | OTTAVA™ Robotic Surgical System | Auris Health, Inc., part of Johnson & Johnson MedTech | SIR | Class II | |
| K261632 | Thunderbolt System | Responsive Arthroscopy | MBI | Class II | |
| K261573 | Endoscope Holder (182214) | AKTORmed GmbH | QZB | Class II | |
| K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | QIH | Class II | |
| K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | QZW | Class II | |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | Macrolux Medical Technology Co., Ltd. | FGB | Class II | |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips | Taiwan Surgical Corporation | FZP | Class II | |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Howmedica Osteonics Corp | ODP | Class II | |
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech LLC | NFT | Class II | |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co.,Ltd. | GEX | Class II | |
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd | OAP | Class II | |
| K261658 | LoFric Origo Pro Coudé | Wellspect Inc. | EZD | Class II | |
| K261614 | LED LCD Monitor (OEV-271H) | LG Electronics.Inc | GCJ | Class II | |
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | BioFire Defense, LLC | PMN | Class II | |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | EIH | Class II | |
| K260694 | Zeiss Clinic 360 | Carl Zeiss Meditec Inc | NFJ | Class II | |
| K254006 | Drivewire 35 Guidewire | Rapid Medical Inc. | MOF | Class II |