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 |
|---|---|---|---|---|---|
| K092772 | Portable X-Ray System, Model Hand-Ray | Hanjin Digi-X Co., Ltd. | EHD | Class II | |
| K092162 | 4Cis Peek, Plif and Tlif Cage System | Solco Biomedical Corp. | MAX | Class II | |
| K090341 | Michigan Cranial Reshaping Orthosis | Danmar Products, Inc. | MVA | Class II | |
| K093520 | Vivosight Topical Oct System | Michelson Diagnostics Ltd | NQQ | Class II | |
| K093465 | Fusion System | Eclipsemed Global, Inc. | ONF | Class II | |
| K093111 | Mikro-Cath, Model 825-0101 | Millar LLC. | DXO | Class II | |
| K092555 | Uno Narrow Implant | MIS Implants Technologies Ltd. | DZE | Class II | |
| K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | LPL | Class II | |
| K090312 | Tria Acne Treatment System, Model Ats-1 OTC | Tria Beauty, Inc. | GEX | Class II | |
| K083384 | Thermodilution Catheter | Biosensors Intl. Pte., Ltd. | DQO | Class II | |
| K092172 | Exel i.v. Extension Set | Exelint Intl. Co. | FPA | Class II | |
| K091557 | Lung Flute Therapeutic | Medical Acoustics | BWF | Class II | |
| K082586 | Lightwave Professional Deluxe | Lightwave Technologies, LLC | GEX | Class II | |
| K093392 | Multipurpose, Nephrostomy and Biliary Drainage Catheters | Boston Scientific Corporation | FGE | Class II | |
| K091541 | Mesa Oxygen Concentrator, Model 2-6000 Series | Sequal Technologies, Inc. | CAW | Class II | |
| K082249 | Morpheus | Meibach Tech Ltda | EJI | Class II | |
| K093139 | Bantam,48xxxxxx, 50Xxxxxx | Clearstream Technologies Ltd. | LIT | Class II | |
| K093006 | Fonix ,Model 8000 | Frye Electronics, Inc. | ETW | Class II | |
| K092906 | Verify Biological Indicator Challenge Pack for Vaporized Vh202 Sterilization | STERIS Corporation | FRC | Class II | |
| K092791 | Kneehab Xp Controller, Model 411 | Bio-Medical Research, Ltd. | IPF | Class II | |
| K092174 | Enabler-P Catheter System, Model 3000 | Endocross, Ltd. | DQY | Class II | |
| K092087 | Medtronic Dental Tcp | Medtronic Sofamor Danek USA Inc | LYC | Class II | |
| K090986 | Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/ Stabilit Erx Bone Cement) | Dfine, Inc. | NDN | Class II | |
| K090920 | Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P) | The Binding Site | CFN | Class II | |
| K093141 | Mars Holter Analysis Workstation | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K093067 | Lipose Disposable Cannula | Lipose Corp. | QPB | Class II | |
| K092929 | Synthes Matrix System | Synthes (USA) Products LLC | NKB | Class II | |
| K092855 | Miltex Membrane Tack Kit | Miltex, Inc. | DZL | Class II | |
| K092588 | Fully Automatic Electronic Blood Pressure Monitor, Model Kd-5910,Kd-5911, Kd-5918 | Andon Health Co., Ltd | DXN | Class II | |
| K091585 | Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100 | KCI USA, Inc. | OMP | Class II | |
| K091227 | Piezosurgery 3; Osstem Piezo | Piezosurgery S.r.l. | DZI | Class II | |
| K093072 | Starcare Handpiece Maintenance Unit | Dentalez, Inc. | EFB | Class I | |
| K093037 | Pentex Ec-3890Li | PENTAX of America, Inc. | FDF | Class II | |
| K092674 | Simpler Toadstool Mini Implant | Pan Global Implant | DZE | Class II | |
| K092450 | Human Igd Kit for Use on Spaplus | The Binding Site | CZJ | Class II | |
| K091851 | Sterile, Powder Free Nitrile Examination Glove, Blue, Tested for Use with Chemotherapy Drugs | Gx Corporation Sdn Bhd | LZA | Class I | |
| K093551 | Paradis Vaso Shield | Spinemedica, LLC | OMR | Class II | |
| K093393 | Lifedop Model 300Abi | Summit Doppler Systems, Inc. | JAF | Class II | |
| K093250 | Proton Therapy Multileaf Collimator | Varian Medical Systems, Inc. | LHN | Class II | |
| K093035 | Fora V10 Blood Glucose Monitoring System, Model Td-4244 | Taidoc Technology Corporation | NBW | Class II | |
| K090959 | Lectrajet Needle-Free Injection System, Model: M3 Ra | D'Antonio Consultants International, Inc. (Dci) | KZE | Class II | |
| K093720 | Sterling Sl Monorail Pta Balloon Dilatation Catheters Sterling Sl Over-the-Wire Balloon Dilatation Catheters Model Vario | Boston Scientific Corporation | LIT | Class II | |
| K093704 | Avs Pl Peek Spacers | Stryker Corp. | MAX | Class II | |
| K093675 | Interfuse Invertebral Body Fusion Device Model 9076 | Vertebral Technologies, Inc. | MAX | Class II | |
| K093663 | Radionuclide Brachytherapy Source | C.R. Bard Inc | KXK | Class II | |
| K093636 | Sterling Es Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model H74939334xxxxxxx | Boston Scientific Corporation | LIT | Class II | |
| K093616 | V. Mueller Camera Controller with Storage Cart | Medtronic, Inc. | OCV | Class II | |
| K093613 | Vascuview Tap Ultrasound System | Escalon Medical Corp | IYN | Class II | |
| K093452 | Fully Automatic Electronic Blood Pressure Monitor Model Kd-571, Kd-7971 | Andon Health Co., Ltd | DXN | Class II | |
| K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/adenovirus Identification Kit | Ortho-Clinical Diagnostics, Inc. | GQS | Class I |