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 |
|---|---|---|---|---|---|
| K071218 | Proxenon 350, Model 902Xx | Welch Allyn Inc | FST | Class II | |
| K070617 | Cannulated Screw | Fournitures Hospitalieres Industrie | HWC | Class II | |
| K070449 | Lumiloc (Tm) Safety Introducer Needle | Specialized Health Products International, Inc. | KNT | Class II | |
| K070444 | Aos Tibial Nail | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | |
| K070336 | Stockert Neuro N50, Model12267 | Stockert GmbH | GXD | Class II | |
| K063876 | Modular Disinfection System (Mds) for Endoscope Reprocessing | Medivators Reprocessing Systems | FEB | Class II | |
| K071458 | Mayfield Radiolucent Disposable Skull Pins | Integra LifeSciences Corporation | HBL | Class II | |
| K071426 | Mp2, X2, Mp5, Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, and Mp90 Intellivue Patient Monitors | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | MHX | Class II | |
| K071408 | X3c 1100 Radiographic Table with Digital Radiographic Detector | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K071378 | Modification to Empower Ct/cta Injector System, Models 9800/9900 Product Series | E-Z-EM, Inc | JAK | Class II | |
| K071376 | Modification to Vertebron Pss Pedicle Screw System | Vertebron, Inc. | NKB | Class II | |
| K071203 | Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy) Soft Contact Lenses | Optikem International, Inc. | LPN | Class II | |
| K071179 | Noras or Head Holder | Siemens Medical Solutions USA, Inc. | MOS | Class II | |
| K071042 | Polarcath Peripheral Dilatation System | Boston Scientific Corporation | LIT | Class II | |
| K070933 | Lowtop Pedicle Screw System | Sanacor | MNH | Class II | |
| K070853 | Dimension Vista Etoh Flex Reagent Cartridge, Model K5022 | Siemens Healthcare Diagnostics Inc. | DIC | Class II | |
| K070580 | Nasopharyngoscope, Bronchoscope | XION GmbH | EOB | Class II | |
| K070403 | Pronto .035 Extraction Catheter | Vascular Solutions LLC | QEZ | Class II | |
| K070255 | Nova Max Blood Glucose Monitor System, 90001,90002 | Nova Biomedical Corporation | NBW | Class II | |
| K070198 | Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length Access Retractors, Hap02 | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K062883 | Gereonics Ultra-Piezo Limb Movement Sensor | Gereonics, Inc. | BZQ | Class II | |
| DEN070006 | Binax Now Malaria Test; Model 660-000, 660-Xxx | Inverness Medical Professional Diagnostics-Binax | OAX | Class II | |
| DEN060002 | Inrange Remote Medication Management System | Inrange Systems, Inc. | NZH | Class II | |
| K071069 | Mini CPAP Device and Humidifier Accessory | Viasys Sleep Systems, LLC | BZD | Class II | |
| K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | CGS | Class II | |
| K061438 | Ultraez Desensitizing Gel | Ultradent Products Inc. | LBH | Class II | |
| K052936 | Thermage Thermacool System | Solta Medical, Inc. | GEI | Class II | |
| K071403 | X3c 1600 Digital Radiographic System | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K071372 | Modification to: Interplate Vbr System | RSB Spine LLC. | MQP | Class II | |
| K071153 | Given Diagnostic System with Pillcam Eso2 Capsule | Given Imaging Ltd. | NSI | Class II | |
| K070891 | Altiva Classic Acp System | Altiva Corp. | KWQ | Class II | |
| K070560 | Lrtm Surgical Mesh | LifeCell Corp | FTM | Class II | |
| K070460 | Allez Spine Cross Connectors | Allez Spine, LLC | NKB | Class II | |
| K070453 | Olympus D-Dimer Reagent, Model Osr6x135, Olympus D-Dimer Calibrator, Model Odr3033, Olympus D-Dimer Control | Olympus Life & Material Science Europa GmbH (Irish | GHH | Class II | |
| K070425 | Vitalstim Experia | Chattanooga Group, Inc. | IPF | Class II | |
| K070281 | Issys Lp Spinal Fixation System | Custom Spine, Inc. | NKB | Class II | |
| K063498 | Hydragel 18 A1at Isofocusing Kit (Pn 4356) | Sebia | OBZ | Class II | |
| K063407 | Bc-3200 Auto Hematology Analyzer | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | GKZ | Class II | |
| K063106 | Revois Implant System | Curasan AG | NHA | Class II | |
| K071409 | X3c 1590 Digital Radiographic System | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K071402 | X3c 1600 Plus Digital Radiographic System | Imaging Dynamics Company, Ltd. | KPR | Class II | |
| K071360 | Optical Guidance Platform | Varian Medical Systems, Inc. | IYE | Class II | |
| K071310 | Syngo CT Oncology Software Package | Siemens Corp. | JAK | Class II | |
| K071241 | Lms-Liver | Median Technologies | LLZ | Class II | |
| K071047 | Masimo Patient Safety Net | Masimo Corporation | MSX | Class II | |
| K070810 | Architect I Theophylline Reagents and Calibrators (a-F) | Biokit, S.A. | LGS | Class II | |
| K070654 | Hyperthermia Pump | Belmont Medical Technologies | LGZ | Class II | |
| K070573 | Synapse System | Synthes Spine Co.Lp | MNI | Class II | |
| K070380 | Portaclamp Flex | Cardio Life Research, S.A. | DXC | Class II |