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 |
|---|---|---|---|---|---|
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | PPT | Class II | |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.io Ltd. | JFY | Class II | |
| K191789 | Stonetome Stone Removal Device | Boston Scientific Corporation | LQR | Class II | |
| K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | HSX | Class II | |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | Abbott Vascular | NTE | Class II | |
| K190910 | PrisMax System Version 2 | Baxter Healthcare Corporation | KDI | Class II | |
| K190819 | Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | Medos International SARL | MBI | Class II | |
| K190292 | Passio Pump Drainage System | Bearpac Medical, LLC | DWM | Class II | |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage | Howmedica Osteonics Corp | MAX | Class II | |
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model | Access Scientific, Inc. | DYB | Class II | |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | JWH | Class II | |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | MXK | Class II | |
| K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | EBW | Class I | |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems Inc | OCC | Class II | |
| K191699 | Discovery XR656 HD with VolumeRad | GE Hualun Medical Systems Co., Ltd. | KPR | Class II | |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | OLO | Class II | |
| K190678 | TempSure | Cynosure, LLC | GEI | Class II | |
| K190587 | Coolrail Linear Pen | AtriCure, Inc. | OCL | Class II | |
| K190471 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Corp. | NKB | Class II | |
| K182984 | MaxiTears Contacts PF | Omnivision AG | MRC | Class II | |
| K182942 | Canon OCT-A1 | Canon, Inc. | OBO | Class II | |
| K191662 | Vantage Orian 1.5T, MRT-1550, V4.5 | Canon Medical Systems Corporation | LNH | Class II | |
| K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | Synthes (USA) Products LLC | HRS | Class II | |
| K190926 | Hammertoe Truss System (HTS) | 4WEB Inc. | HTY | Class II | |
| K190488 | ProLift Expandable System | Life Spine | MAX | Class II | |
| K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | Grandway Technology (Shenzhen) Limited | DXN | Class II | |
| K191374 | Revival Modular Hip Stem | Corin USA | LZO | Class II | |
| K191092 | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | Anhui Intco Medical Products Co., Ltd. | LYZ | Class I | |
| K191078 | BAROnova Access Sheath Kit | Baronova, Inc. | QGG | Class II | |
| K190975 | Plexus SCD110 Sequential Compression Device Sleeve | Midway Medical | JOW | Class II | |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | LZO | Class II | |
| K182985 | Roadrunner PC Wire Guide, Olcott Torque Device | Cook Incorporated | DQX | Class II | |
| K182817 | CottonDay Tampon | Taebong Co.,Ltd. | HEB | Class II | |
| K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster Inc | DQK | Class II | |
| K182487 | CerusEndo Microcatheter | Cerus Endovascular, Inc. | DQY | Class II | |
| K191757 | EUROPA Pedicle Screw System | Mirus, LLC | NKB | Class II | |
| K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | NKB | Class II | |
| K191633 | Infyna Chic | Hollister Incorporated | GBM | Class II | |
| K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Canon Medical Systems Corporation | IYN | Class II | |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | JGS | Class II | |
| K191309 | syngo.via MI Workflows VB40A, Scenium | Siemens Medical Soultions USA, Inc. | LLZ | Class II | |
| K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | NQQ | Class II | |
| K190260 | STERIZONE(R) VP4 Sterilizer | Tso3, Inc. | PJJ | Class II | |
| K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica S.P.A | GYB | Class II | |
| K183545 | Anspach Helix Dissection Tools | The Anspach Effort, Inc. | HBE | Class II | |
| K183349 | AeroDVx System | Sun-Scientific Inc. | JOW | Class II | |
| K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | OVB | Class II | |
| K182940 | Surdial DX Hemodialysis System | Nipro Medical Corporation | KDI | Class II | |
| K182798 | KIDScore D3 | Vitrolife Inc. | PBH | Class II |