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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K072241 | Primaconnex Cad/cam Abutment System | Lifecore Biomedical LLC | NHA | Class II | |
| K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536 | Kapp Surgical GmbH | NEU | Class II | |
| K072156 | Optimus 0.035 Inch Pta Balloon Dilatation Catheter | Usci Ireland | DQY | Class II | |
| K071918 | Chillbuster Portable Electric Blanket, Model 8002 | Thermogear, Inc. | DWJ | Class II | |
| K071890 | Zodiac 4.0 Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | MNH | Class II | |
| K071826 | The Rinspirator, Models Fg09770, Fg08776, Fg08777, Fg08910 | Medtronic, Inc. | QEZ | Class II | |
| K071813 | Mastergraft Putty | Medtronic Sofamor Danek | MQV | Class II | |
| K071802 | Tesla Guard, Model Eft G04 | Mammendorfer Institut Fur Physik und Medizin GmbH | MWI | Class II | |
| K071760 | Modification to: Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | |
| K071724 | Lucent | Spinal Elements, Inc | MAX | Class II | |
| K071619 | Spy Fluorescent Imaging System | Novadaq Technologies ULC | IZI | Class II | |
| K071413 | Hemicap Patello-Femoral Resurfacing System | Arthrosurface, Inc. | KRR | Class II | |
| K071059 | Depuy Spa Porous Coated Proximal Sleeve | Depuy Orthopaedics Inc. | KWZ | Class II | |
| K070935 | T.b.r. Zirconnect | Sudimplant SA | DZE | Class II | |
| K063852 | Accessa Cholesterol Panel | Home Access Health Corp. | JKA | Class II | |
| K062607 | Polygraft Bgs | Smith & Nephew, Inc. | MQV | Class II | |
| K072960 | Cdp 5000, Media and Distribution Center, Diagnet | Cdp, Ltd. | LLZ | Class II | |
| K072710 | Nexfix Compression Pin | Nexa Orthopedics, Inc. | JDW | Class II | |
| K072586 | Conformis Uni-Condylar Knee System | ConforMIS, Inc. | HSX | Class II | |
| K072359 | Aearo Company Surgical N95 Respirators, Models N9508c and N9511c | Aearo Company | MSH | Class II | |
| K072247 | Sterican Hypodermic Needles | B.Braun Medical, Inc. | FMI | Class II | |
| K072245 | Emulate Advanced | Cavex Holland B.V. | ELW | Class II | |
| K072240 | Gunther Tulip Vena Cava Filter | Cook Inc. | DTK | Class II | |
| K072014 | Vitascore | Vitascore B.V. | MNR | Class II | |
| K071957 | Pinnacle Pelvic Floor Repair Kits | Boston Scientific Corporation | OTP | Class III | |
| K070569 | Sm Internal./external Implant System | Dio Department Dsi, Inc. | DZE | Class II | |
| K062264 | Complete Se Self Expanding Biliary Stent System | Medtronic, Inc. | FGE | Class II | |
| K073010 | Royale Ae 9036 Lsp Injector | Asico, LLC | MSS | Class I | |
| K072956 | Medihoney Primary Dressings with Active Manuka Honey | Derma Sciences, Inc. | FRO | Unclassified | |
| K072646 | Unicaprone | United Medical Industries Co. Ltd. | GAM | Class II | |
| K072645 | Uniglactin | United Medical Industries Co. Ltd. | GAM | Class II | |
| K072644 | Unicryl Quick | United Medical Industries Co. Ltd. | GAM | Class II | |
| K072423 | 4.5Mm Locking Broad & Narrow Compression Plates, 4.5Mm & 5.5Mm Cortical & Cancellous Locking Screws, Respectively. | Depuy Orthopaedics Inc. | HRS | Class II | |
| K072135 | Kronus Gad Autoantibody Elisa Assay Kit | Kronus Market Development Associates, Inc. | NWG | Class II | |
| K071711 | Asca-Chek | Techlab Inc., Corporate Research Center | NBT | Class II | |
| K071165 | Iscalert Sensor System | Alertis Medical AS | CCC | Class II | |
| K071151 | Tension Band Anterior Spinal System | Spinal Instrumentation Simplification Systems, LLC | KWQ | Class II | |
| K073021 | Multi-Spect | Eagle Heart Imaging, LLC | KPS | Class II | |
| K072972 | Medstreaming Medical Office Software | Medstreaming, LLC | LLZ | Class II | |
| K072896 | Gs Fixture System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K072894 | Surflo Winged Infusion Set with Needle Protection (Surshield) | Terumo Europe N.V. | FPA | Class II | |
| K072576 | Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the Clearlink Antimicrobial Luer Activated | Baxter Healthcare Corporation | FPA | Class II | |
| K072430 | Zoll Pedipadz Reduced Energy Electrode | ZOLL Medical Corporation | MKJ | Class III | |
| K072053 | Smartblock Pain Pump | Medical Flow Systems, Ltd. | MEB | Class II | |
| K071388 | Gentian Cystatin C Immunoassay | Gentian AS | NDY | Class II | |
| K071365 | Agento I.c. Silver-Coated Endotracheal Tube | C.R. Bard Inc | BTR | Class II | |
| K070550 | Ausco Es-3100 | Koratek Company, Ltd. | DQD | Class II | |
| K072868 | Accolade II Laser | Cynosure, LLC | GEX | Class II | |
| K072794 | Immulite 2500 Om-Ma, Model L5kop | Siemens Healthcare Diagnostics Inc. | LTK | Class II | |
| K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | JOW | Class II |