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 |
|---|---|---|---|---|---|
| K042843 | Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators | Ambu, Inc. | BTM | Class II | |
| K042749 | Genemax Power Wheelchair, Pw4 | Genemax Medical Products Industry Corp. | ITI | Class II | |
| K042748 | Genemax Power Wheelchair, Pw3 | Genemax Medical Products Industry Corp. | ITI | Class II | |
| K042718 | 13C/1h Occipital Headcoil for Magnetom Allegra | Siemens Medi Cal Solutions, Inc. | MOS | Class II | |
| K042611 | Lunderquist Extra Stiff Double Curved Exchange Wire Guide | Cook Inc. | DQX | Class II | |
| K042291 | Unicel Dxc 600 and 800 Synchron Systems | Siemens Healthcare Diagnostics Inc. | CEM | Class II | |
| K042250 | Sensatouch | Aluna Management Co., Ltd. | IYO | Class II | |
| K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | BIOCOMPATIBLES U.K. Limited, a BTG Company | HCG | Class II | |
| K042216 | Cool-Tip RF Ablation System | Medtronic, Inc. | GEI | Class II | |
| K042144 | Nicom | Cheetah Medical, Inc. | DXG | Class II | |
| K041967 | Genicon Suction Irrigation System | Genicon, Inc. | GCJ | Class II | |
| K041595 | Toe Mp Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 | Biopro, Inc. | KWD | Class II | |
| K043018 | Omron Digital Blood Pressure Monitor, Model Hem-906 | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K042888 | Demetron Ids Curing Light | Sybron Dental Specialties, Inc. | EBZ | Class II | |
| K042853 | Full Automatic (Nibp) Blood Pressure Monitor, Models Hl888ea, Hl888cf, Hl888gf and Hl888qa | Health & Life Corporation | DXN | Class II | |
| K042816 | Traumacad 1.2 | Orthocrat, Ltd. | LLZ | Class II | |
| K042752 | Accupach V | Accutome Ultrasound, Inc. | IYO | Class II | |
| K042475 | Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator Kit 20; Vitros Chemistry Produc | Ortho-Clinical Diagnostics, Inc. | CFN | Class II | |
| K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | IYO | Class II | |
| K042171 | Ax's Endo 04, 06, 08, 2.5, 40 , Models 50100206, 50100217, 50100218, 50100230, 50100232 | Micro-Mega Societe Anonyme | EGS | Class I | |
| K041903 | Fujinon G5 Colonoscopes, Models Ec-450Hl5 and Ec-250Hl5 | FUJIFILM Healthcare Americas Corporation | FDF | Class II | |
| K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Company | MSH | Class II | |
| K041818 | Sonicath Ultra Imaging Catheter 3.2F 20Mhz, Models 37410/456221/C1020 | Boston Scientific Corporation | ITX | Class II | |
| K041680 | Orajel Advanced Tooth Desensitizer | Del Pharmaceuticals, Inc. | KLE | Class II | |
| K042949 | Pelvilace Transobturator Biourethral Support System (Pelvilace to System) | C.R. Bard Inc | PAG | Class II | |
| K042935 | Gemini Gxl | Philips North America LLC | KPS | Class II | |
| K042882 | Enteryx Injection Catheter | Boston Scientific Corporation | FBK | Class II | |
| K042851 | Mentor Obtape Trans-Obturator Surgical Kit | Mentor | OTN | Class II | |
| K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | LZO | Class II | |
| K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K042555 | Surgichip Tag Surgical Marker | Surgichip, Inc. | FZZ | Class I | |
| K042029 | X-Series Integral Rpp Femoral Components | Zimmer GmbH | LPH | Class II | |
| K041170 | Secur-Fit Ha and Secur-Fit Plus Hip Stems | Howmedica Osteonics Corp | LZO | Class II | |
| K041075 | Fastin Rc Anchor | DePuy Mitek, Inc. | HWC | Class II | |
| K041069 | Spiralok Anchor | DePuy Mitek, Inc. | HWC | Class II | |
| K042969 | Modification to Smart Control Nitinol Stent Transhepatic Biliary System | Cordis US Corp. | FGE | Class II | |
| K042811 | Vivosorb Sheet, Model Fs01 | Polyganics B.V. | FTL | Class II | |
| K042753 | Mammotome Mr Biopsy System | Ethicon Endo-Surgery Inc | KNW | Class II | |
| K042700 | Image Medical Acquisition Station (Imas) | Erad Imagemedical Corp. | LLZ | Class II | |
| K042566 | Vasc-Alert | Vasc-Alert, LLC | MQS | Class II | |
| K042557 | Innoject Auto-Injector | Innoject, Inc. | KZH | Class II | |
| K042550 | Multi-Lipid Calibrator | FUJIFILM Healthcare Americas Corporation | JIX | Class II | |
| K042549 | Multi Chem Cal B | FUJIFILM Healthcare Americas Corporation | JIX | Class II | |
| K042538 | Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx | Invatec Innovative Technologies, S.r.l. | DQY | Class II | |
| K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx | Invatec Innovative Technologies, S.r.l. | DQY | Class II | |
| K042527 | Spatula, Cervical, Cytological, Model 22-9107 | Medical Action Industries, Inc. 306 | HHT | Class II | |
| K042516 | Otomimix | Biomet Microfixation | NEA | Class II | |
| K042438 | Superdimension/bronchus | Medtronic, Inc. | JAK | Class II | |
| K042228 | Beeline Motiv, Propolis, Pca | Mckinley, Inc. | FRN | Class II | |
| K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems | Surgical Laser Technologies, Inc. | GEX | Class II |