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 |
|---|---|---|---|---|---|
| K980754 | Cir Latex Examination Gloves, Non-Sterile, Powdered, with Protein Labeling Claim of <=200 Ug/g | Crocker Industrial Resources Sdn. Bhd. | LYY | Class I | |
| K980610 | Dexon Rapid (Dexon R) | Davis & Geck, Inc. | GAM | Class II | |
| K980609 | Segmental Defect Replacement System | Metagen, LLC | HSB | Class II | |
| K980584 | Atlasplan | Radionics, Inc. | HAW | Class II | |
| K980379 | Prowess Pro-Sim | Ssgi Prowess Systems | IYE | Class II | |
| K980354 | Cryptosporidium Test | Techlab, Inc. | MHJ | Class II | |
| K974534 | Micro-Plate Cotinine Eia | OraSure Technologies, Inc. | MKU | Class I | |
| K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson MEDICAL GmbH | DXQ | Class II | |
| K974015 | Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central | Davis & Geck, Inc. | FOZ | Class II | |
| K973892 | Rusch Blakemore Tube - 4 Lumen (Minnesota Type) | Rusch Intl. | KNT | Class II | |
| K973789 | Norian Cranial Repair System (Crs)bone Cement- 5Cc Kit, Norian Cranial Repair System (Crs) Bone Cement- 10Cc | Norian Corp. | GXP | Class II | |
| K972114 | Olympus Sonosurg System | Olympus Optical Co., Ltd. | LFL | Unclassified | |
| K970726 | Vapocide | Cottrell, Ltd. | MED | Class II | |
| K981179 | Lovytex Powder-Free Nitrile Examination Gloves | Lovytex Sdn Bhd | LZA | Class I | |
| K981073 | Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack | Medcom Laundry Service, Inc. | FYA | Class II | |
| K981000 | Carrara Porcelain and Carrara Vincent Porcelain | European Dental Imports, Inc. | EIH | Class II | |
| K980793 | Q-Luxpro V/q-Luxpro II Light Cure Unit | Rolence Enterprise Co., Ltd. | EBF | Class II | |
| K980792 | Cu-100A Light Cure Unit | Rolence Enterprise Co., Ltd. | EBF | Class II | |
| K980732 | 3M Cdi Quick-Cells with Heparin Treatment | 3M Healthcare | DRY | Class II | |
| K980647 | Eye Irrigator Model #2020 | Eye-Deal Ocular Safety Products, Inc. | KYG | Class I | |
| K980620 | Dentatus Mti Modular Transitional Implants and Prosthetic System | Dentatus USA Ltd. | DZE | Class II | |
| K980575 | Siteseer Angiographic Catheter | C.R. Bard Inc | DQO | Class II | |
| K980210 | Various Surgical or Patient Drapes | Gel-Lite, LLC | KKX | Class II | |
| K980014 | The System 2S Steam Sterilizer | STERIS Corporation | FLE | Class II | |
| K971077 | Covertip Safety Syringe | Medisys Technologies, Inc. | MEG | Class II | |
| K981239 | Deroyal Industries Disposable Laparoscopic Clip Applier with Implantable Titanium Clips | Deroyal Surgical | FZP | Class II | |
| K980935 | Capiox Sx Hardshell Reservoir | Terumo Medical Corp. | DTN | Class II | |
| K974584 | Fresenius F Series Hemoconcentrators F400,f500,f700,f800,f400ts,f500ts,f700s,f800ts | Fresenius USA, Inc. | KDI | Class II | |
| K974234 | Micro-Plate Cotinine Eia | OraSure Technologies, Inc. | MKU | Class I | |
| K973920 | Stardust | Respironics, Inc. | MNR | Class II | |
| K971421 | Bard Isoflow Blood Pump | C.R. Bard Inc | DWA | Class II | |
| K981455 | Third Generation Psa Control Module | Siemens Healthcare Diagnostics Inc. | JJY | Class I | |
| K981413 | Schneider Guider Softip Guiding Catheters | Boston Scientific Corporation | DQY | Class II | |
| K980649 | Preference Standard, Preference Toric, Cooper Toric, Cooperclear, Cooperht, Cb 43, Vantage, Vantage Accents | CooperVision, Inc. | LPL | Class II | |
| K980603 | Etest Trovafloxacin | Ab Biodisk | JWY | Class II | |
| K980548 | Dura-Patch Model Dp-Xxx | Bridger Biomed, Inc. | GXQ | Class II | |
| K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | GEX | Class II | |
| K974491 | Accu-Chek A1c Hemoglobin Test | Boehringer Mannheim Corp. | LCP | Class II | |
| K974008 | Pfleiderer's Intratympanic Catheter | Exmoor Plastics Limited | ETD | Class II | |
| K971374 | Greatbatch Scientific Mr Compatible Hysteroscope | Wilson Greatbatch Technologies, Inc. | HIH | Class II | |
| K971207 | Softlight Q-Switched (Nd:yag) Laser | Thermolase Corp. | GEX | Class II | |
| K981532 | Lyphochek Immunoassay Plus Control | Bio-Rad | JJY | Class I | |
| K981427 | Stat Profile M Analyzer | Nova Biomedical Corporation | GKF | Class II | |
| K981426 | Stat Profile Ultra F,g,h,i,j,k, and L Analyzers | Nova Biomedical Corporation | GKF | Class II | |
| K981425 | Stat Profile Ultra a, B, C, D, and E Analyzers | Nova Biomedical Corporation | GKF | Class II | |
| K981256 | Isolated Saline Electrodes/probes/devices-Salinetrode | Ximed/Prosure/Injectx | FAS | Class II | |
| K981231 | CO2 | Abbott Mfg., Inc. | KHS | Class II | |
| K981059 | Acetaminophen-Sl Assay, Catalogue # 505-10, 505-30. | Sekisui Diagnostics P.E.I. Inc. | LDP | Class II | |
| K980859 | Hemocor Hph Mini Hemoconcentrator | Medivators Inc | KDI | Class II | |
| K980857 | Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing Electrode | Graphic Controls Corp. | MKJ | Class III |