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 |
|---|---|---|---|---|---|
| K071706 | Envoy 500 Hdl; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118) | Clinical Data, Inc. | LBS | Class I | |
| K071482 | Stryker RF Multi-Lesion Generator, Model 0406-900-000 | Synergetics Inc | GXD | Class II | |
| K071187 | Microfuse Bone Void Filler | Globus Medical, Inc. | MQV | Class II | |
| K071063 | Linasys | Pathfinder Therapeutics, Inc. | OEW | Class II | |
| K071026 | Bd Geneohm Staphsr Assay | BD Diagnostics (Geneohm Sciences Canada, Inc) | NQX | Class II | |
| K063686 | Depuy Lps Distal Femoral Component | Depuy Orthopaedics Inc. | JWH | Class II | |
| K073423 | MRI Powerport Implanted Port with 9.6 Fr Silicone Catheter | C.R. Bard Inc | LJT | Class II | |
| K073408 | Ge Logiq Bt08 Diagnostic Ultrasound System | GE Medical Systems Ultrasound and Primary Care Dia | IYN | Class II | |
| K073360 | Proplate | Bio Protech, Inc. | GEI | Class II | |
| K073350 | Scanora 3D | Soredex Palodex Group Oy | MUH | Class II | |
| K073340 | Color Lcd Monitor, Flexscan Mx300w | Eizo Nanao Corporation | LLZ | Class II | |
| K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | OBR | Unclassified | |
| K073205 | Nio 5Mp, Model Mdng-5121 | Barcoview, Medical Imaging Systems | LLZ | Class II | |
| K073196 | Master-Vu | Sonomed, Inc. | IYO | Class II | |
| K073117 | Dentin Desensitizer Agent | Dentsply Intl. | LBH | Class II | |
| K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | |
| K072997 | Neomed Urinary Catheter | Halyard Health | EZD | Class II | |
| K072961 | Lotus Ultrasonic System for Cemented Implant Extraction (Uscix) | SRA Developments Ltd | JDX | Class II | |
| K072951 | Parietene Duo and Quadra Polypropylene Meshes | Sofradim Production | OTP | Class III | |
| K072810 | Pronto Low Profile (Lp) Extraction Catheter, Model 5010 | Vascular Solutions LLC | QEZ | Class II | |
| K072756 | Non-IV Adapter for Infant Ng Tube | Promedic, Inc. | KNT | Class II | |
| K072707 | Patient Contoured Mesh-Peek (Pcm-P) | KLS-Martin L.P. | GXN | Class II | |
| K072592 | Performax Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | BZD | Class II | |
| K072547 | Jbaids Tularemia Detection Kit, Model Jrpd-Asy-0124 | Idaho Technology, Inc. | OEH | Class II | |
| K072478 | Baylis Pain Management Generator-Td, Models: Pmg-115-Td and Pmg-230-Td | Baylis Medical Co., Inc. | GEI | Class II | |
| K072466 | Statim 7000 (without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101 | Scican Ltd. | FLE | Class II | |
| K072168 | OTC Abdomen & Thigh System, Model: Wl-2410, Wl-2411 and Wl-2412 | Well-Life Healthcare Limited | NGX | Class II | |
| K072078 | Quantia Beta-2 Microglobulin, Model: 302822307 | Biokit, S.A. | JZG | Class II | |
| K071781 | Pf4 Igg | Immucor GTI Diagnostics, Inc. | LCO | Class II | |
| K071691 | Dual Shot Alpha | Nemoto Kyorindo Co., Ltd. | DXT | Class II | |
| K071616 | Arc Surgical Biotrak Pin System | Arc Surgical, LLC | HTY | Class II | |
| K071210 | Modification to Fidis Connective 10*, Model Mx006 | Biomedical Diagnostics (Bmd) SA | LKO | Class II | |
| K070873 | Amsure Bladder Irrigation Set | Amsino Intl., Inc. | LJH | Class II | |
| K073373 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | JAK | Class II | |
| K073297 | Ge Logiq P6 | General Electric Co. | IYN | Class II | |
| K073045 | Sapphire Ceramic Bracket | Ortho Technology | NJM | Class II | |
| K073001 | Idrives, Idrivec, Idrivef | Power Medical Interventions, Inc. | GDW | Class II | |
| K072995 | Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser | Lumen Development and Manufacturing, Inc. | GEX | Class II | |
| K072796 | Meerci Retriever, Concentric Microcatheter, Models 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 | Concentric Medical, Inc. | DQO | Class II | |
| K072758 | Synthes (USA) 2.0Mm Titanium T-Plate | Synthes (USA) Products LLC | GWO | Class II | |
| K072676 | Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K072588 | Performax Se Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | CBK | Class II | |
| K072537 | Creaspine Supstance Vertebral Body Replacement System | Creaspine SAS | MQP | Class II | |
| K072271 | Stryker Navigation System Infinitus Hip Resurfacing Module | Stryker Corp. | HAW | Class II | |
| K072180 | Vision-Sciences Cst-5000 Video Cystoscope with Endosheath System | Cogentix Medical, Inc. | FAJ | Class II | |
| K072146 | Ems Piezon Master Surgery | E.M.S. - Electro Medical Systems SA | DZI | Class II | |
| K071995 | Cg-6108 Continuous ECG Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | DSI | Class II | |
| K071930 | One Step Hcg Urine Pregnancy Test (Strip), Model B01-S, One Step Hcg Urine Pregnancy Test (Cassette) , Model B01c | Blue Cross Bio-Medical Co., Ltd. | LCX | Class II | |
| K071537 | Sterrad 100Nx Test Pack | Advanced Sterilization Products | FRC | Class II | |
| K070356 | Medwaves Microwave Coagulation/ablation System | Medwaves Incorporated | NEY | Class II |