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 |
|---|---|---|---|---|---|
| K234106 | Venue Fit | GE Healthcare | IYN | Class II | |
| K233767 | OmniTom Elite | Samsung HME America, Inc. | JAK | Class II | |
| K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) | KARL STORZ Endovision, Inc. | FGB | Class II | |
| K241423 | Access Thyroglobulin | Siemens Healthcare Diagnostics Inc. | MSW | Class II | |
| K241069 | iLoop Interventional Coil 0.55T | NORAS MRI products GmbH | MOS | Class II | |
| K241038 | Cardiac CT Function Software Application | Circle Cardiovascular Imaging Inc | QIH | Class II | |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) | Medline ReNewal | NLH | Class II | |
| K240832 | Blood Pressure Monitor (BBZ32-AA01) | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K240672 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) | Zhejiang Zahndent Biotechnology Co.,Ltd | EIH | Class II | |
| K240570 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | |
| K234099 | Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant | Select Labs, LLC | NUC | Class II | |
| K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.Ai, Co., Ltd. | QIH | Class II | |
| K233861 | Libre Rio Continuous Glucose Monitoring System | Abbott Medical | SBH | Class II | |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC. | NLH | Class II | |
| K232969 | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | PKL | Class II | |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | bioMerieux, Inc. | NGZ | Class II | |
| K232837 | Uro-G HD Flexible Cystoscope | Uroviu Corporation | FAJ | Class II | |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen le Medical Technology Co., Ltd. | DPS | Class II | |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| K232804 | FibriCheck | Qompium NV | QME | Class II | |
| K232625 | Steriking® Pouch for Robotic Instruments | Wipak Oy | FRG | Class II | |
| K232035 | Impala | AliveCor | DPS | Class II | |
| K231010 | Corvair | AliveCor | MHX | Class II | |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | NBW | Class II | |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Halyard Health | KNT | Class II | |
| K240963 | Spinal System | Teslake, Inc. | NKB | Class II | |
| K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | OLO | Class II | |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care Inc. | QJP | Class II | |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- | LivsMed Inc. | GEI | Class II | |
| K240202 | Conical Platform Dental Implants System | Noris Medical Ltd. | DZE | Class II | |
| K233824 | Swan-Ganz catheter | Edwards Lifesciences LLC | DYG | Class II | |
| K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | MJC | Class II | |
| K232968 | Grande Medical Masks, Model SF-600 | Golden Grande Corp. | FXX | Class II | |
| K232774 | Wearable Breast Pump,Model S18 | Ningbo Dearevery Electronic Technology Co., Ltd. | HGX | Class II | |
| K241262 | Baby Gorilla/Gorilla Plating System; Monster Screw System | Paragon 28 | HRS | Class II | |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation Inc. | FLL | Class II | |
| K240603 | Ti-Base & Master Fix | ARUM DENTISTRY Co., Ltd. | NHA | Class II | |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | ISA | Class I | |
| K240211 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | |
| K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems Inc | DZE | Class II | |
| K240008 | Mobility Scooter (W3331) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K233008 | Cannulated Headless Bone Screws | AAP Implantate AG | HWC | Class II | |
| K241258 | Ingenix Spinal System | Ingenium Spine | NKB | Class II | |
| K240877 | Monteris Medical NeuroBlate System | Monteris Medical Corp | ONO | Class II | |
| K240627 | LIAISON PLEX Yeast Blood Culture Assay | Luminex Corporation | PEO | Class II | |
| K240505 | Eminent Spine SI Screw System | Eminent Spine | OUR | Class II | |
| K240463 | Slow Wave DS8 (SWDS802) | Slow Wave, Inc. | MQC | Unclassified | |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) | Aesthetic Technology Ltd | GEX | Class II | |
| K240100 | SAM Model 9-10000 | Snap Diagnostics, L.L.C. | MNR | Class II |