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 |
|---|---|---|---|---|---|
| K083089 | Newport Spinal System | Seaspine, Inc. | NKB | Class II | |
| K083082 | Moorvms-Ldf1 and Moorvms-Ldf2 Laser Doppler Perfusion and Temperature Monitors | Moor Instruments Ltd. | GEX | Class II | |
| K082605 | Vpap Auto with Humidaire 3I | ResMed Corp | BZD | Class II | |
| K082488 | Diazyme Lp(a) Assay | General Atomics | DFC | Class II | |
| K082089 | Prumyx Cream | Prugen, Inc. | FRO | Unclassified | |
| K081230 | Trauson Intramedullary Nail | Trauson (Jiangsu) Medical Instrument Co., Ltd. | HSB | Class II | |
| K080299 | Respifit S, Model Rs-Lr1001004 | Eumedics Medizintechnik und Marketing GmbH | BWF | Class II | |
| K072971 | Topcon 3D Oct-1000 Optical Coherence Tomography System for Measurement of Retinal Thickness | Topcon Healthcare, Inc. | OBO | Class II | |
| K083240 | Opus Magnum2 and Opus Magnum X Knotless Fixation Devices | ArthroCare Corporation | MBI | Class II | |
| K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products | GEI | Class II | |
| K083145 | Asahi Guide Wire Extension, Model Ag149000 | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K083036 | Voco Profluorid L | Voco GmbH | LBH | Class II | |
| K082936 | Powder-Free Vinyl Patient Examination Gloves | Zibo Litong Plastic Products Co., Ltd. | LYZ | Class I | |
| K082905 | Medrad Stellant CT Injector System with P3t Cardiac | Medrad, Inc. | DXT | Class II | |
| K082787 | Vital Signs Monitor, Model: Md500b | Beijing Choice Electronic Technololgy Co., Ltd. | MWI | Class II | |
| K082746 | Ultra Iabp Catheter Kit, Models Imu7f-40, Imu7f-35, Imu7f-30, Imu7f-25, Imu7f-20 | Insightra Medical Inc | DSP | Class II | |
| K082622 | Alma Lasers Accent B-Shape Massager Handpiece/module | Alma Lasers Ltd. | NUV | Class II | |
| K082231 | Ascension Silicone Pip | Ascension Orthopedics, Inc. | KYJ | Class II | |
| K083730 | Isolaz | Aesthera Corporation | GEX | Class II | |
| K083701 | Panasil Initial Contact and Panasil Tray | Kettenbach GmbH & Co KG | ELW | Class II | |
| K083682 | 180W Cerelas D 980Nm Diode Laser, Model D180 | Biolitec, Inc. | GEX | Class II | |
| K083664 | Fora Td-4245 Blood Glucose Monitoring System, Td-4245 | Taidoc Technology Corporation | CGA | Class II | |
| K083522 | Sony Up-Df750 Digital Film Imager | Sony Electronics Inc. | LMC | Class II | |
| K083416 | Revolve Stabilization System | Globus Medical, Inc. | NKB | Class II | |
| K083358 | Lubricano-Ultrasound | Farco Pharma GmbH | MUI | Class II | |
| K083332 | Md21m 21.3 Diagnostic Imaging Lcd Monitor, Model L218tk | Nec Display Solutions, Ltd. | LLZ | Class II | |
| K083331 | Confidant, Model 2.6 | Confidant, Inc. | DRG | Class II | |
| K083061 | Ellex Innovative Imaging Eye Cubed V4 | Ellex, Inc. | IYO | Class II | |
| K083060 | Reprocessed Harmonic Scalpel | Sterilmed Inc | NLQ | Unclassified | |
| K082917 | Mastergraft Resorbable Ceramic Granules | Medtronic Sofamor Danek | LYC | Class II | |
| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000Ml), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000Ml) | Dynarex Corp. | KNT | Class II | |
| K082808 | Imagesvr Pacs | Jaguar Technology Limited | LLZ | Class II | |
| K082704 | Birthtrack (A.k.a. Clm) | Barnev, Ltd. | NPB | Class II | |
| K082660 | V60 Ventilator, Model V8000 | Respironics, Inc. | MNT | Class II | |
| K082466 | Xycor Spinal Implant | Vertebration,Inc | MQP | Class II | |
| K081956 | Medinol X-Suit Nir Biliary Metallic Stent | Medinol Ltd. | FGE | Class II | |
| K081767 | Amnisure Fetal Membranes Rupture Test, Model Fmrt-1 | Amnisure International, LLC | NQM | Class I | |
| K083721 | Modification to Zenieva | River'S Edge Pharmaceuticals, LLC | NAE | Class I | |
| K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | KPR | Class II | |
| K083274 | Worldwide Medical Technologies Anchor Marker, Marker Strand and Marker | Biocompatibles, Ltd. | KXK | Class II | |
| K081895 | Advia Chemistry Hemoglobin A1c, Advia Chemistry A1c Calibrators | Siemens Healthcare Diagnostics Inc. | LCP | Class II | |
| K081703 | Myglucohealth Glucose Monitoring Systems | Entra Health Systems | NBW | Class II | |
| K080431 | Rapidsense Drugs of Abuse Phencyclidine (Pcp) 25 Device with Models 900-0054 | Quantrx Biomedical Corporation | LCM | Unclassified | |
| K072882 | Pain Vision, Model Ps-2100 | Osachi Co., Ltd. | LLN | Class I | |
| K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | HRS | Class II | |
| K082941 | Biomerix Composite Surgical Mesh, Model Smnr-0510 and Smnr-1215 | Biomerix Corporation | FTL | Class II | |
| K082827 | A-Dec/w&h Profin Reciprocating Contra-Angle Handpiece Attachment | A-dec, Inc. | EFB | Class I | |
| K082789 | G1b Pulse Oximeter | General Meditech, Inc. | DQA | Class II | |
| K082598 | Powder Free Blue Patient Nitrile Examination Glove | Tangshan Zhonghong Pulin Group Co., Ltd. | LZA | Class I | |
| K081924 | Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse | Calhealth, Inc. | DXN | Class II |