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 |
|---|---|---|---|---|---|
| K900910 | Cobe Air Emboli Protection System (Aeps) | Cobe Laboratories, Inc. | DTW | Class II | |
| K900857 | Non Sterile Parenteral Supply Kit | Intermed, Inc. | FMF | Class II | |
| K900824 | Fluor-I-Chains(tm) and Fluor-I-Ties(tm) | Midwest Orthodontic Mfg. | EJF | Class I | |
| K900034 | Angio-Max | Accumed Systems, Inc. | DXT | Class II | |
| K894763 | Fujinon Edu System | FUJIFILM Healthcare Americas Corporation | ITX | Class II | |
| K902038 | Patho Dx Strep D | Siemens Healthcare Diagnostics Inc. | GTZ | Class I | |
| K901408 | The Tongue Brush | Garry Laboratories, Inc. | LCN | Class I | |
| K901243 | Chlamydia-Cel Immunofluorenscence (If) Test | Cel Labs Pty, Ltd. | LJP | Class I | |
| K900941 | Omnipatch | Eye Garter Company, Inc. | HOY | Class I | |
| K900908 | Controlled Distention Irrigation System Cdis 200 | Zimmer GmbH | HIG | Class II | |
| K893576 | Siemens Model 284 Pp | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K893575 | Siemens Model 283 Asp | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K893574 | Siemens Model 284 Pp-Agc | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K893573 | Siemens Model 284 Pp-L | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K893071 | Patient Exam Gloves (Mfg. Koon Seng) | Innovative Medical Suppliers | LYY | Class I | |
| K902139 | Hemagen Ena [Jo-I] Kit | Hemagen Diagnostics, Inc. | DHN | Class II | |
| K902017 | Latex Patient Examination Gloves | Taksin Rubber Industries Co., Ltd. | LYY | Class I | |
| K901903 | Patient Examination Gloves | Southland Products Co., Ltd. | LYY | Class I | |
| K901855 | Latex Patient Examination Glove | Tower Marketing Sdn. Bhd. | LYY | Class I | |
| K901364 | Hgp II Total Hip Femeral Stem | Zimmer GmbH | JDI | Class II | |
| K901286 | Amicon Hemoconcentrator Set | Amicon, Inc. | KDI | Class II | |
| K901218 | Life Aid Resuscitator | Clarendon Supplies, Ltd. | BTM | Class II | |
| K901119 | Ohmeda Modulus Cd Anesthesia System | GE Healthcare | BSZ | Class II | |
| K901079 | Single-Use, Sterile 4Oz Bottle Contain Ster. Water | L H M Ent., Inc. | BTO | Class II | |
| K901078 | Single-Use, Sterile 4Oz Bottle Contain 0.9% Saline | L H M Ent., Inc. | BTO | Class II | |
| K900929 | Putterman-Scott, Socket Reconstruction Bilateral | Oculo Plastik, Inc. | HQX | Class II | |
| K900909 | In-Line Vial Connection Site | Baxter Healthcare Corporation | FPA | Class II | |
| K900873 | Pediatric Hospital Bed | Hospital Supply Co., Inc. | FMS | Class II | |
| K900872 | Wheeled Stretcher | Hospital Supply Co., Inc. | FPO | Class II | |
| K900786 | Visi-Sorb Absorbant Stick | Visitec Co. | HOZ | Class II | |
| K900687 | Syringe Disposal System | National Syringe Disposal, Inc. | FMF | Class II | |
| K900470 | In-the Nebulizer | Hudson Oxygen Therapy Sales Co. | CAF | Class II | |
| K900127 | Ferris Hydrophilic Dressing (Add'l Indications) | Ferris Mfg. Corp. | KMF | Class I | |
| K900119 | Latex Patient Examination Gloves | Cen Tex Industrial Co., Ltd. | LYY | Class I | |
| K896269 | Sechrist Volume Ventilator Model 2200B | Sechrist Industries Inc | CBK | Class II | |
| K895735 | Deseret Multilumen Subclavian Catheter | Deseret Medical, Inc. | LYY | Class I | |
| K895115 | Frank Inhaler Thermal S | Buttner-Frank GmbH | CCQ | Class I | |
| K893072 | Patient Exam Gloves (Mfg. Sun Flower Glove Co.) | Innovative Medical Suppliers | LYZ | Class I | |
| K892305 | Patient Examination Gloves (Latex) | Hemipan Trading & Mfg. Co. (P), Ltd. | LYY | Class I | |
| K892217 | Cav Sat Oximeter Model 100 | Somanetics Corp. | DQA | Class II | |
| K901577 | Milenia(tm) Opiates | Siemens Healthcare Diagnostics Inc. | DJG | Class II | |
| K901568 | Milenia(tm) Cannabinoids | Siemens Healthcare Diagnostics Inc. | LDJ | Class II | |
| K901561 | Iron/total Iron Binding Capacity | Tech-Co, Inc. | JIY | Class I | |
| K901080 | Ez-Bead Phenytoin Enzyme Immunoassay Kit | IMMUNOTECH s.r.o. | DIP | Class II | |
| K901031 | Pci Model 2041-Pc Telemetry Monitor | Accucore, Inc. | DRT | Class II | |
| K900813 | Bard Short Rigid Ureteroscope | C.R. Bard Inc | FGB | Class II | |
| K900761 | Ams Optilume(tm) Prostate Balloon Dilator | American Medical Systems, Inc. | KOE | Class II | |
| K900760 | Ams Optilume Inflation Syringe | American Medical Systems, Inc. | KOE | Class II | |
| K900758 | Heparinized Arterial Screen Blood Filter | Cobe Laboratories, Inc. | DTM | Class II | |
| K900599 | Microplate Reagent Dispenser | Denley Instruments, Inc. | JQW | Class I |