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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K851230 | Gambro Pressure Monitor Guards | Gambro, Inc. | FIB | Class II | |
| K851144 | Ureteral Dilation Set | Van-Tec, Inc. | EZN | Class II | |
| K850959 | Equipment Snap Kovers | Advance Medical Designs Inc | JAA | Class II | |
| K850826 | Posidyne Solution Container Filter, Recorder #96 | Pall Biomedical Products Co. | FPB | Class II | |
| K850825 | Aef Posidyne i.v. Filter/air Eliminator | Pall Biomedical Products Co. | FPB | Class II | |
| K850729 | Acuflo Volumetric Controlled Delivery Sys 2000 | Surgidev Corp. | FRN | Class II | |
| K850674 | Cormed II Ambulatory Infusion Pump | Cormed, Inc., Sub. C.R.Bard, Inc. | FRN | Class II | |
| K850669 | Prominject Programmable Infusion Pump | Pharmacia, Inc. | FRN | Class II | |
| K850653 | Imed 440 Infusion Pump & Administration Set | Imed Corp. | FRN | Class II | |
| K850568 | Model 78231D Cardiac Output Module | Hewlett-Packard Co. | DXG | Class II | |
| K850365 | Recording Accessory for G-2000 EKG Mach. GMP-40 Re | Eaton Medical Group | DSF | Class I | |
| K850349 | Viggo Arterial Cannula | Viggo Products | FOZ | Class II | |
| K850278 | Vasculon i.v. Cannulae | Viggo Products | FOZ | Class II | |
| K850246 | Master Kit a | Pro-Lab, Inc. | |||
| K850188 | Bosch in the Ear Hearing Aid Superstar | Robert Bosch Corp. | ESD | Class I | |
| K850167 | }Iustim - Electronic Neuromuscular Stimulator | Urologics, Inc. | KPI | Class II | |
| K850132 | Disposable Conductive Adhesive Diagnostic ECG Elec | Consolidated Medical Equipment Company | DRX | Class II | |
| K850130 | Prn ECG Electrode | Consolidated Medical Equipment Company | DRX | Class II | |
| K850118 | Xma Integrated Table | Summit Industries, LLC | IXQ | Class II | |
| K850117 | Xma 325 (X-Ray Generator) | Summit Industries, LLC | IZO | Class I | |
| K850019 | Omni Phase Penile Prosthesis | Dacomed Corp. | FAE | Class II | |
| K844997 | Iai Program-Computer Program | Intl. Acoustics, Inc. | DXG | Class II | |
| K844843 | Ivac Drug Administration Device | Y | FPA | Class II | |
| K844101 | Cardio-Nec Model 365 | Birtcher Corp. | DPS | Class II | |
| K851208 | Compact Exchange Device 5C4197 | Travenol Laboratories, S.A. | KDJ | Class II | |
| K851207 | Extended Life Capd Solution Transfer Set 5C4153 | Travenol Laboratories, S.A. | KDJ | Class II | |
| K851110 | Gaylor-Thoms Uterine Biopsy Forceps 1810-144 Pcs. | The Huxley Instrument Corp. | HFB | Class I | |
| K850999 | Technicon Gen 2 Sys & Analytes Ld, Alp Ck, Un, in | Technicon Instruments Corp. | JJF | Class I | |
| K850987 | Medix Visual Serumo Hcg L10/10 Test Hcg Enzyme Imm | Medix Biotech, Inc. | JHI | Class II | |
| K850903 | Data Zyme CO2 Procedure | Data Medical Associates, Inc. | KHS | Class II | |
| K850831 | Strep a Quick | Abbott Medical | GTZ | Class I | |
| K850824 | Photo Clearfil a. a Light Cured Adhes. Dental Rest | Kuraray Co. | EBF | Class II | |
| K850821 | Cerestore Dentin Porcelain | Johnson & Johnson Professionals, Inc. | EIH | Class II | |
| K850728 | Model 4000 Nd:yag Laser for Gastrointestional Blee | Cooper Lasersonics, Inc. | LNK | Class II | |
| K850604 | Preco Pregnancy Rapid Card Test, Hem #2028 | Preco, Inc. | JHJ | Class II | |
| K850509 | Nd:yag Fiberlase 100 Medical Laser System | Laser Media | LNK | Class II | |
| K850375 | Microsurgery Visibility Background Material | Ethicon, Inc | |||
| K850256 | Confirm Immunoassay for Detecttion Strep-Pyogenes | Abbott Medical | GTZ | Class I | |
| K850068 | Lune Au Curettes | Luneau Laboratories | HCY | Class I | |
| K850053 | Baci 6 -Adrenocorticotroop Hormone | Euro-Diagnostics BV | CKG | Class II | |
| K850013 | Sys Stim 206(Model-Me 206) Muscle Stimulator | Mettler Electronics Corp | IPF | Class II | |
| K844862 | Post-Auricular Hearing Aid Model Pe 600Ppch | Phonic Ear, Inc. | ESD | Class I | |
| K844765 | Accessory Set for CO2 Laser Bronchoscopy Instrumen | Laser Spectrum, Inc. | EWQ | Class I | |
| K844670 | Korvin Vita Radiopaque Plastic Teeth | Credent Co. | ELM | Class II | |
| K844597 | Miscellaneous General Surgical Custom Kit | Xanmed Corp. | |||
| K842687 | Biomedics Bladder Scanner | Biomedics | ITX | Class II | |
| K851060 | Emit Qst N-Acetylprocainamide Assay | Syva Co. | LAN | Class II | |
| K850797 | Tempalert Liquid Crystal Thermometer | Medical Frontiers, Inc. | KPD | Class II | |
| K850265 | American Twa Way Filter -Bacterial/viral-Retentive | American Pharmaseal Div. Ahsc | CAH | Class II | |
| K850181 | Aequitron Med-7100 Phototherapy Light | Aequitron Medical, Inc. | LBI | Class II |