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 |
|---|---|---|---|---|---|
| K182420 | ASAHI Corsair Pro XS | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K182320 | BD Contoured Base Pen Needle | Becton Dickinson & Co | FMI | Class II | |
| K182165 | Color Doppler Ultrasound System; Model: mEye1 and mEye2 | Shenzhen Well.D Medical Electronics Co., Ltd. | IYN | Class II | |
| K181861 | Embrace | EMPATICA S.r.l. | POS | Class II | |
| K181838 | Sinusway Dilation System | 3NT Medical Ltd. | LRC | Class I | |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | PAM | Class II | |
| K181589 | Curiteva Lumbar Interbody Fusion System | Curiteva, Inc. | MAX | Class II | |
| K180830 | Reuter Tip Deflecting Wire Guide | Cook Incorporated | DQX | Class II | |
| K180828 | Natureplex Warm Touch Warming Jelly | Natureplex LLC | NUC | Class II | |
| K173041 | 3DIEMME RealGUIDE | 3DIEMME SRL | LLZ | Class II | |
| K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| DEN170072 | Enlight 1810 | Timpel S.A. | QEB | Class II | |
| DEN170021 | SEM Scanner (Model 200) | Bruin Biometrics, LLC | QEF | Class I | |
| K183239 | CoreLink F3D™ Lateral System | Corelink, LLC | MAX | Class II | |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | DiaSorin Molecular LLC | OZZ | Class II | |
| K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic, Inc. | OCL | Class II | |
| K182446 | TruShot with Y-Knot All-Suture Anchor | ConMed Corporation | MBI | Class II | |
| K182190 | Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. | KNG | Class II | |
| K182149 | FFRangio System | Cathworks Ltd. | QEK | Class II | |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | MAH | Class II | |
| K181785 | Modified BrainScope One | Brainscope | PIW | Class II | |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | Taidoc Technology Corporation | BTA | Class II | |
| K180846 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | DQO | Class II | |
| K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | NBW | Class II | |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Hollister Incorporated | GBM | Class II | |
| K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration System) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | |
| K182989 | AURORA™ Screw System | Mirus, LLC | HWC | Class II | |
| K182938 | Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K182878 | Integra Salto Total Ankle System | Ascension Orthopedics, Inc. | HSN | Class II | |
| K182747 | EliA RF IgM Immunoassay | Phadia AB | DHR | Class II | |
| K182688 | Skr 3000 | Konica Minolta, Inc. | MQB | Class II | |
| K182624 | MIM - MRT Dosimetry | MIM Software Inc | LLZ | Class II | |
| K182595 | HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K182593 | KET-1 Blood Ketone Monitoring System | Apex Biotechnology Corp. | JIN | Class I | |
| K182424 | NuFACE FIX Skin Toning Device | Carol Cole Company dba NuFACE | NFO | Class II | |
| K182422 | Lucitone Denture Base Materials | Dentsply Sirona Inc | EBI | Class II | |
| K182361 | Arthrex Compression FT Screws | Arthrex GmbH | HWC | Class II | |
| K182150 | Devon 52 Sequential Compression Device | Devon Medical Products (Jiangsu) Ltd | JOW | Class II | |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | AprioMed AB | FCG | Class II | |
| K181496 | Vintage Pro | Shofu Dental Corp. | EIH | Class II | |
| K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd | LQY | Unclassified | |
| K180909 | REVEL Spacers | Globus Medical, Inc. | ODP | Class II | |
| K183348 | Reusable Silicone Cover CPRmeter 2 | Laerdal Medical a/S | LIX | Class II | |
| K183198 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | |
| K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co.,Ltd. | DXQ | Class II | |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk a/S | FMF | Class II | |
| K182001 | Acucy Influenza A&B Test with the Acucy System | Sekisui Diagnostics, LLC | PSZ | Class II | |
| K181877 | Phoenix 2.4mm Atherectomy Plus System | Volcano Atheromed, Inc. | MCW | Class II | |
| K181612 | Tyto Stethoscope (OTC) | Tyto Care Inc. | DQD | Class II | |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx | Shanghai Venture Bio-Tech Co., Ltd. | DJC | Class II |