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 |
|---|---|---|---|---|---|
| K170122 | Delta III Lithotripter | Dornier Medtech America, Inc. | LNS | Class II | |
| K163153 | Livia | Lifecare, Ltd. | NUH | Class II | |
| K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | HRX | Class II | |
| K171590 | Distal Elbow Plating System | Skeletal Dynamics, Inc | HRS | Class II | |
| K171536 | RayStation | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K171163 | Contact Lens Case Round Glasses | Fiftytwoways, Ltd. | LRX | Class II | |
| K170817 | Halcyon | Varian Medical Systems, Inc. | IYE | Class II | |
| K170735 | Powder-Free Clear Vinyl Patient Examination Gloves | Zibo Yue Fan Medical Products Co, Ltd. | LYZ | Class I | |
| K170708 | Owl RF Insulated Cannulae | Diros Technology, Inc. | GXI | Class II | |
| K170297 | Tranquil Interbody System | Nexus Spine, L.L.C. | MAX | Class II | |
| K163432 | Stellar LEAP | Pdg Product Design Group Inc | IOR | Class I | |
| K163216 | Pinpoint GT Needles | C.R. Bard Inc | BSP | Class II | |
| K162874 | Cannulated Screws Neoortho | Neoortho Produtos Ortopedicos S/a | HWC | Class II | |
| K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | MAX | Class II | |
| K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit | SPR Therapeutics, Inc | NHI | Class II | |
| K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | DPS | Class II | |
| K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics Inc. | LPH | Class II | |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | Lin-Zhi International Inc | DJR | Class II | |
| K170045 | Swedge™ Pedicle Screw Fixation System | Spinal Resources Inc | NKB | Class II | |
| K162797 | SpringTMS | eNeura Inc | OKP | Class II | |
| K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | Medline ReNewal | NUJ | Class II | |
| K171188 | Ossler Exam Scope | Lr Med, Inc. | DRG | Class II | |
| K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | DQY | Class II | |
| K171009 | LASEMD Laser System | Lutronic Corporation | GEX | Class II | |
| K170759 | CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation | KTI | Class II | |
| K170620 | ReBOSSIS85 | Orthorebirth Co Ltd | MQV | Class II | |
| K170302 | Yellow Laser Photocoagulator Ylc-500 | Nidek Co., Ltd. | HQF | Class II | |
| K170270 | Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline | Ls Scientific Inc. D.B.A. Kse Scientific | FRO | Unclassified | |
| K170094 | Powder Free Latex Examination Glove, Polymer Coated | Vietglove Corporation | LYY | Class I | |
| K163668 | Suitestensa | Ebit SRL | LLZ | Class II | |
| K163449 | HyPHo Laser System | Hyper Photonics S.r.l. | GEX | Class II | |
| K163437 | hypodermic Pinpoint™ GT Needle | C.R. Bard Inc | PVZ | Class II | |
| K162993 | Gemini Sterilization Wrap | MEDLINE INDUSTRIES, LP - Northfield | FRG | Class II | |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser | Siemens Healthcare Diagnostics Inc. | OYE | Class II | |
| K162821 | Babyleo TN500 | Draegerwerk AG & Co. KGaA | FMZ | Class II | |
| K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | Roche Diagnostics GmbH | LGD | Class II | |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | Fisher & Paykel Healthcare, Inc. | HIF | Class II | |
| K153138 | Cerdak Basic | Bu Polysciences Equipment & Trading, LLC | FRO | Unclassified | |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | KTW | Class II | |
| K171591 | CUBEScan™ BioCon-900 (Bladder Volume Measurement System) | MCUBE TECHNOLOGY Co.,Ltd. | IYO | Class II | |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | ODE | Class II | |
| K171047 | Sterile Polyisoprene Powder Free Surgical Gloves | Better Care Plastic Technology Co., Ltd. | KGO | Class I | |
| K170933 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | |
| K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | Innovative Health, LLC. | NLH | Class II | |
| K170883 | FilmArray NGDS Warrior Panel | BioFire Defense, LLC | PRD | ||
| K170727 | VariAx 2 Compression Plating System | Stryker Corp. | HRS | Class II | |
| K170629 | Vitruvian Infiltration Pump | Black & Black Surgical, Inc. | QPB | Class II | |
| K170299 | Ion PGM Dx System | Life Technologies Corporation | PFF | Class II | |
| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | Girgis Scope, LLC | CCW | Class I | |
| K163399 | Tria Firm Ureteral Stent | Boston Scientific Corporation | FAD | Class II |