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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K895632 | Sarns Membrane Oxygenator W/integral Cadio. 16380 | 3M Company | DTZ | Class II | |
| K895397 | Calcium and Ph Electrolyte Analyzer | Ionetics, Inc. | JFP | Class II | |
| K895208 | Zymed Model 1610 | Agilent Technologies, Inc. | DSI | Class II | |
| K894355 | Disp. Gel External Pacing & Defibrillation Elect. | Phycon | LDD | Class II | |
| K893207 | Closed Chest Support Circuit | Medtronic Blood Systems, Inc. | DTZ | Class II | |
| K896625 | Thromboplastin, for Use in Prothrombin Time Deter. | Medical Diagnostic Technologies, Inc. | GJS | Class II | |
| K896399 | White Magnolia Denudate Latex Examination Gloves | Prime Horizon, Inc. | LYY | Class I | |
| K896335 | Clp Glycosylated Hemoglobin Control-Nr | Creative Laboratory Products, Inc. | LCP | Class II | |
| K896334 | Clp Glycosylated Hemoglobin Control-Er | Creative Laboratory Products, Inc. | LCP | Class II | |
| K896306 | Glove N Gel | Ems Medical, Inc. | LYY | Class I | |
| K895848 | Pressure Steam Sterilizers | Scientific Device Laboratory, Inc. | FLE | Class II | |
| K895708 | Ebna Antibody Test System (Immunofluorescent Anti) | IMMUNO CONCEPTS, NA, Ltd. | LLM | Class I | |
| K895675 | Pap Smear Tray | Intl. Cytobrush, Inc. | HHT | Class II | |
| K895657 | Patient Examination Gloves (Non Sterile) | Ka Hung Development, Ltd. | LYY | Class I | |
| K895637 | Latex Exam Gloves (Mfg. Super Glove Industry Co.) | Transcontinental Fertilizer Co. | LYY | Class I | |
| K894213 | Spring Latex Examination Gloves | Brandywine Surgical, Inc. | LYY | Class I | |
| K893513 | Patient Examination Glove/manuf. Kun Shan Factory | Pioneer Sundries Products, Ltd. | LYY | Class I | |
| K892636 | Patient Examination Gloves (Latex) | P.T. Latexindo Parama | LYY | Class I | |
| K892091 | Patient Examination Gloves (Latex) | Rising Crown Industries, Ltd. | LYY | Class I | |
| K896694 | Ventrezyme Vast Specific Ige Assay | Ventrex Laboratories, Inc. | DHB | Class II | |
| K896292 | 1.2 Micron Filter with IV Set | Kendall Mcgaw Laboratories, Inc. | FPB | Class II | |
| K896069 | Wilson-Cook Gianturco-Rosch Biliary Z Stent | Wilson-Cook Medical Inc. | FGE | Class II | |
| K895707 | Ebna Antibody Test System (Immunoenzyme Antibody) | IMMUNO CONCEPTS, NA, Ltd. | LLM | Class I | |
| K895676 | Hemostat/stimulator Probe | Rln Systems, Inc. | ETN | Class II | |
| K895630 | B-D Pend Needle | BD Becton Dickinson Vacutainer Systems Preanalytic | FMI | Class II | |
| K895523 | Phase II Orthodontic Adhesive | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K895508 | Calasept Paste | Js Dental Mfg., Inc. | EJK | Class II | |
| K895502 | Microtek Reuter-Style Bi-Valve Intranasal Splint | Microbio-Medics, Inc. | EPP | Class I | |
| K895473 | Dsx(tm), Digital Sx, Quantum Dsx, Model 4700S | Medical Devices Inc. | GZJ | Class II | |
| K894939 | Percutaneous Endoscopic Gastrostomy Tray | North American Sterilization & Packaging Co. | FPD | Class II | |
| K894068 | Kirschner Unicompartmental Knee System | Kirschner Medical Corp. | HSX | Class II | |
| K884920 | Rectum-Colon Motility Monitor | Multi-Spectrum Consulting, Inc. | FAP | Class II | |
| K884890 | Lord L.f.r. Total Hip System | Howmedica Corp. | JDI | Class II | |
| K895816 | Bio-Rad Blind Perfor. Specimen Set for Nida Reg. | Bio-Rad | DIF | Class I | |
| K895789 | Unipolar Temp. Myocardial Heart Wire, Model 6490 | Medtronic, Inc. | LDF | Class II | |
| K895782 | Neonatal Incubator (Accessory) | Air-Shields Vickers, Inc. | FMZ | Class II | |
| K895779 | Modified Permcath Tray (2Nd Submission) | Quinton, Inc. | CBK | Class II | |
| K895721 | Millar Mikro-Tip Pulse Transducer | Millar LLC. | DXO | Class II | |
| K895703 | Diatek Model 700 Thermometer | Diatek, Inc. | FLL | Class II | |
| K895661 | Glycotest II Glyhb Assay Kit | Pierce Chemical Co. | LCP | Class II | |
| K895550 | K-1 Infant Transport System | K-1 Medical Products, Inc. | FMZ | Class II | |
| K895522 | Light Bond Paste W/fluoride | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K895521 | Rely-a-Bond W/fluoride (No Mix Adhesive) | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K895421 | Cortisol Test System | Baxter Healthcare Corporation | JFT | Class II | |
| K892377 | Rmi Aortic Root/coronary Sinus Monit./infusion Set | Research Medical, Inc. | DTL | Class II | |
| K892368 | Rmi Cardioplegia Delivery Sets | Research Medical, Inc. | DTL | Class II | |
| K883852 | Catheter, Cardiovascular, Balloon Type | Wb Intl., Inc. | DXE | Class II | |
| K896601 | Exactech Bone Screw | Exactech, Inc. | HWC | Class II | |
| K896538 | Disposable 45 Degree Shaver | Bowen & Company, Inc. | HRX | Class II | |
| K896383 | Disposable External Clamps | Galenica Enterprises, Inc. | GDI | Class I |