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 |
|---|---|---|---|---|---|
| K903306 | Technicon Chem I System Magnesium Method | Technicon Instruments Corp. | JGJ | Class I | |
| K903108 | Patient Exam Gloves (Finish W/usp Starch Powder) | Ansell, Inc. | LYY | Class I | |
| K903107 | Patient Exam Gloves (Dusted W/usp Starch Powder) | Ansell, Inc. | LYY | Class I | |
| K903094 | Stat Test Hdl/cholesterol Test Kit | Diagnostic Resources, Inc. | LBR | Class I | |
| K903052 | Immunocorp Lh Irma Coated Tube | Immunocorp Sciences, Inc. | CEP | Class I | |
| K903003 | Mps Diamond Polishing Gel | Abrasive Technology, LLC | EJR | Class I | |
| K902854 | Gravity Assist | Instrument Makar, Inc. | KYZ | Class I | |
| K902770 | Patient Examination Glove | Mastri Lieno, PT | LYY | Class I | |
| K902687 | Steri-Cath-Dl | Concord/Portex | BSY | Class I | |
| K902436 | Hg Multilock Hip Prosthesis W/tinidium Surface | Zimmer GmbH | JDI | Class II | |
| K902402 | High Speed Non-Fiber Optic Swivel Handpiece | Dentalez Group | EBF | Class II | |
| K902278 | PVC Patient Examination Glove | Fujian Province Jiu Zhou Group | FMC | Class I | |
| K902009 | Elantec's Surgical Tape Remover | Elantec, Inc. | KOX | Class I | |
| K901756 | Interjector Blood Collection Device | Bowman/Vector, Inc. | JKA | Class II | |
| K901755 | Model 3001 Syringe Infusion Pump | Medfusion, Inc. | FRN | Class II | |
| K901016 | Laser-Shield Ii(tm) | Xomed, Inc. | GEX | Class II | |
| K900483 | Varidyne at Postoperative Orthopedic Autotransfu. | Baxter Healthcare Corporation | CAC | Class II | |
| K900273 | Trach Care Mdi Adapter | Ballard Medical Products | CAF | Class II | |
| K903202 | Toy Sunglasses | Creative Design | HQY | Class I | |
| K902817 | Surgi Pak Ne and Cocoment Eugenal Free Paste Syst | Confi-Dental Products Co. | EMA | Class II | |
| K902798 | Automated Hydrosonics(tm) | Alcon Surgical, Inc. | HQC | Class II | |
| K902694 | Coaxial Catheter Set | Cook Ob/Gyn | HDR | Class II | |
| K902460 | Cardioscint (Left Ventricular Function Monitor) | Oakfield Instruments, Ltd. | IZD | Class I | |
| K902392 | Coltosol Temporary Endodontic Filling Material | Coltene, Inc. | EMA | Class II | |
| K902070 | Radius and Sonochrome | General Electric Co. | ITX | Class II | |
| K901417 | Electrostim Mst | Promatek Industries, Ltd. | GZJ | Class II | |
| K901066 | Vitalmax 500 Pulse Oximeter W/temp. and Respira. | Pace Tech, Inc. | DQA | Class II | |
| K900493 | The Precisionist | Paradigm Medical, Inc. | HQC | Class II | |
| K897090 | Sunglasses | Pt Midas Surya Optical Co. | HQY | Class I | |
| K903726 | Drape, Surgical - Utility Drape - Sterile | Graham Medical Products | KKX | Class II | |
| K902585 | Uroplasty Tcu Prostatic Urethroplasty Catheter | Advanced Surgical Intervention, Inc. | KOE | Class II | |
| K901131 | Ysi Model 1500 Sport L-Lactate Analyzer | Yellow Springs Instrument Co., Inc. | KHP | Class I | |
| K900468 | Lifecare(r) Model 3 Pump | Abbott Medical | FRN | Class II | |
| K900467 | Lifecare Model 4 Pump | Abbott Medical | FRN | Class II | |
| K896918 | Mouse Anti-Human Leucocyte Antigen & Dako Pap Kit | Dako Corp. | DEH | Class II | |
| K903652 | Scan Com and Scan Com P (Tentative) | Med Labs, Inc. | ILQ | Class II | |
| K902737 | Bc Brushes | Olympus Corp. | FDX | Class II | |
| K902736 | Nm Injection Needles | Olympus Corp. | FBK | Class II | |
| K902477 | Workstation Femoral Intravascular Retrieval Set | Medical Engineering and Development Institute | DYB | Class II | |
| K902396 | Modified Depuy Acetabular Cup System | Depuy, Inc. | JDI | Class II | |
| K902395 | Modified Aml + Acetabular Cup System | Depuy, Inc. | JDI | Class II | |
| K901849 | Lumiscope Ems 8000 | Lumiscope Co., Inc. | IPF | Class II | |
| K903442 | Aries Taperseal(tm) Sheath | Aries Medical, Inc. | DYB | Class II | |
| K903430 | Liquichek Ck/ld Isoenzyme Control; Levels 1 and 2 | Bio-Rad | JJT | Class I | |
| K903352 | Prolax Disposable Latex Gloves (Examination) | Prolax Medical Products, Inc. | LYY | Class I | |
| K903350 | Prolax Disposable Latex Gloves (Exam) Hypoallergen | Prolax Medical Products, Inc. | LYY | Class I | |
| K903218 | Imx B12 | Abbott Medical | LIG | Class II | |
| K903095 | Il Thyroxine (T4) Assay System | Instrumentation Laboratory Co. | KLI | Class II | |
| K902954 | Ober2 Monitor, Eye Movement (Ophthalmic) | Permobil, AB | HFC | Class II | |
| K902933 | Teslacon (Magnetic Resonance Diagnostic Device) | General Electric Co. | LNH | Class II |