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 |
|---|---|---|---|---|---|
| K090850 | Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute | Apatech Ltd. | LYC | Class II | |
| K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls | Lin-Zhi International Inc | DJG | Class II | |
| K090812 | Theraform Standard/sheet | Sewon Cellontech Co., Ltd. | KGN | Unclassified | |
| K090224 | Fortex Pedicle Screw System | Xtant Medical Holdings, Inc. | MNH | Class II | |
| K090203 | 5.5 Helical Flange Spinal System, Polaris Components | Ebi, LLC | NKB | Class II | |
| K083870 | Exsalt Sd7 Wound Dressing | Exciton Technologies Inc. | FRO | Unclassified | |
| K083719 | Lncs Oximetry Sensors | Masimo Corporation | NLF | Class II | |
| K083334 | Elasto-Gel Manuka Honey Wound Dressing | Southwest Technologies Inc | FRO | Unclassified | |
| K083131 | Medos Hilite Reservoir, Model: 4030 | Gish Biomedical, Inc. | DTN | Class II | |
| K092179 | Aplio Xg Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001 | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K092054 | Moxie Plastic Applicator and Moxie Non-Applicator Tampon | Tosama D.D. | HEB | Class II | |
| K091788 | Panta Nail (Dia. 10Mm), Panta Nail Xl | Newdeal SAS | HSB | Class II | |
| K091594 | Heart-Exercise | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K091405 | Pillcam Platform with Pillcam Sb Capsules with Pillcam Sensorbelt | Given Imaging Ltd. | NEZ | Class II | |
| K091403 | Mod1t Compensators for Radiation Beam Therapy | Oncology Tech, LLC | IXI | Class II | |
| K091197 | Planmeca Prosensor | Planmeca Oy | EHD | Class II | |
| K090996 | Ponto Pro | Oticon Medical AB | LXB | Class II | |
| K090210 | Modification to Olympus Capsule Endoscope System | Olympus Medical Systems Corp. | NEZ | Class II | |
| K090054 | Atlas Implant System - Wide Plus | Cowellmedi Co., Ltd. | DZE | Class II | |
| K083409 | Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label | WRP Asia Pacific Sdn Bhd | LZC | Class I | |
| K083242 | Neurosign Avalanche Motor Nerve Monitor | Magstim Inc. | ETN | Class II | |
| K082093 | Bullseye Biliary Stent System | Squareone | FGE | Class II | |
| K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | IYN | Class II | |
| K092023 | Naviject Sub2-1P, Model: Lp604430 | Medicel AG | MSS | Class I | |
| K091829 | Pls Portable Light Source | Optim LLC | NTN | Class II | |
| K091690 | Sharp Chute | Heathrow Scientific, LLC | MMK | Class II | |
| K091519 | Haemoband Multi-Ligator | Haemoband Surgical Ltd | FHN | Class II | |
| K091459 | Philips Nm3 Monitor, Model 7900 | Respironics Novametrix, LLC. | BZK | Class II | |
| K091285 | Al T Laser, Model Avi Hpll-12 | Avicenna Laser Technology, Inc. | ILY | Class II | |
| K090828 | Non-Sterile, Powder Free Nitrile Examination Gloves | Ultrawin Sdn Bhd | LZA | Class I | |
| K090733 | Pmt Halo System | PMT Corp. | HAX | Class II | |
| K083052 | Euroimmun Anti-Gliadin (Gaf-3X) Elisa (Iga) | Euroimmun US Inc. | MST | Class II | |
| K092122 | Global Shoulder Steptech Anchor Peg Glenoid | Depuy Orthopaedics Inc. | KWS | Class II | |
| K091663 | Powder-Free Vinyl Patient Examination Gloves | Zhangjiagang Fengyuan Plastic Products Co., Ltd. | LYZ | Class I | |
| K091661 | Powder-Free Vinyl Patient Examination Gloves | Zhang Jia Gang Huayuan Plastic Co., Ltd. | LYZ | Class I | |
| K091147 | Powder Free Nitrile Examination Glove (Blue) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K091054 | Walk400h | Et Medical Devices SpA | MWJ | Class II | |
| K090738 | Thermoflo Hch, Thermoflo Filter | Arc Medical, Inc. | CAH | Class II | |
| K090699 | Variant II Turbo Hba1c Kit Kit-20 and Wash/diluent Solution Set, Models 270-2455, 270-2730 | Bio-Rad Laboratories Inc. | LCP | Class II | |
| K090477 | Alpine Pedicle Screw System | Sanacor | MNH | Class II | |
| K090154 | Spi Dental Implant Inicell | Thommen Medical AG | DZE | Class II | |
| K083614 | Sonolith I-Sys Lithotriper | Technomed Medical Systems, SA | LNS | Class II | |
| K083377 | Accupen | Accutome Ultrasound, Inc. | HKX | Class II | |
| K092030 | Elation Mb Metal Reinforced Plastic Bracket | Dentsply Interntional | DYW | Class II | |
| K091985 | Universal Physiological Measurement Module | Ivy Biomedical Systems, Inc. | DRT | Class II | |
| K091580 | Pica Whole Body MRI System | Time Medical Limited | LNH | Class II | |
| K091577 | Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw System | Extremity Medical, LLC | HWC | Class II | |
| K091513 | Smart ECG Series Electrocardiograph, Models Se-3, Se-300A and 300B, Se-6, Se-600, Se-12, Se-12 Express and Se-1200 | Edan Instruments, Inc. | DPS | Class II | |
| K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | MEDTOX Diagnostics, Inc. | DJG | Class II | |
| K091294 | Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010, Compression Fusion Plate, | Depuy Orthopaedics Inc. | HRS | Class II |