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 |
|---|---|---|---|---|---|
| K894948 | Platelia Toxo Igm Kit | Kallestad Diag, A Div. of Erbamont, Inc. | LGD | Class II | |
| K894610 | Custom Trays, Kits | L H M Ent., Inc. | FSM | Class I | |
| K901022 | Powered Inflatable Tube Massager, Sport-Med | Damor America, Inc. | IRP | Class II | |
| K900692 | Dahlberg Model Jms in-the-Ear Hearing Instrument | Miracle-Ear, Inc. | ESD | Class I | |
| K900593 | Technicon H*2(tm) System | Technicon Instruments Corp. | GKZ | Class II | |
| K900461 | Opus Model 4021, Vvi, 5Mm Unipolar | Ela Medical, Inc. | DXY | Class III | |
| K900452 | Quattro Catheter | Ep Technologies, Inc. | DRF | Class II | |
| K900296 | Safetex/suntex Sterile Surgical Latex Gloves | P.T. Latexindo Prautama | KGO | Class I | |
| K900191 | Mct Composite Chair | Medical Composite Technology, Inc. | IOR | Class I | |
| K900050 | Miracle Ear Model Ck in-the-Ear Hearing Aid | Miracle-Ear, Inc. | ESD | Class I | |
| K897184 | 3F and 4F Irrigation Embolectomy Catheters | Cathlab Corp. | DXE | Class II | |
| K897116 | Optima Mpt Model 5281E and Model 5282E | Telectronics Pacing Systems, Inc. | DXY | Class III | |
| K897101 | Disposable Prophy Angle and Accessories | Dentsply Intl. | EFB | Class I | |
| K897027 | Teethmate-a | Kuraray Co. | EBC | Class II | |
| K897020 | All-Bond Dentin Bonding System | Bisco, Inc. | KLE | Class II | |
| K896766 | Td-28 Disposable Electrode | Med USA | GXY | Class II | |
| K896588 | Oncoprobe II System | Care Wise Medical Products Corp. | IZD | Class I | |
| K896048 | S-Rom/noiles Mark 3 | Joint Medical Products Corp. | KRO | Class II | |
| K895017 | Sorba Model Cic-1000, Comp. Impedance Cardiograph | Sorba Medical Systems, Inc. | DXG | Class II | |
| K893004 | Hearing Aid (All-in-the-Ear) | Hearing Specialists of Nevada, Inc. | ESD | Class I | |
| K901030 | Rotary Communication Scanner Model 7010 | Baylor Biomedical Services | ILQ | Class II | |
| K901029 | Yes-No Voice Box 7011 | Baylor Biomedical Services | ILQ | Class II | |
| K901028 | Environmental Control Unit Model 7000 | Baylor Biomedical Services | IQA | Class II | |
| K900997 | K-Sterile TENS Electrodes | Katecho LLC | GXY | Class II | |
| K900969 | Remote Control Switch | Baylor Biomedical Services | IQA | Class II | |
| K900660 | Tomoscan Stereotaxis Simulation Software | Philips North America LLC | JAK | Class II | |
| K900606 | 'Conductor' Disposable TENS Electrode | Medical Science Products, Inc. | GXY | Class II | |
| K900553 | Constant Current Stimulator Model 022101 | Ep Technologies, Inc. | JOQ | Class II | |
| K900517 | Rapid Nf System | Innovative Diagnostic Systems, Inc. | JSW | Class I | |
| K900195 | Modified Gore-Tex Surgical Tape | W. L. Gore & Associates, Inc. | MCA | Class II | |
| K897171 | Disposable CO2 Absorber/e | Gibeck, Inc. | CBL | Class I | |
| K897127 | Atrium 2052 Chest Drain, Dual Collection Blood | Atrium Medical Corporation | CAC | Class II | |
| K897126 | Atrium 2050 Chest Drain Blood Recovery System | Atrium Medical Corporation | CAC | Class II | |
| K897115 | Angiorex C/n (Angiographic X-Ray System) | Toshiba America Medical Systems, In.C | IZI | Class II | |
| K897004 | Nova Microsonics Datavue Echo Analysis System | Advanced Technology Laboratories, Inc. | DXG | Class II | |
| K896958 | Escort Non-Invasive Blood Pressure Option | Medical Data Electronics | DXN | Class II | |
| K896950 | Core Build Up Composite | Confi-Dental Products Co. | EBF | Class II | |
| K896621 | L.t.c. Replacement Gastrostomy Tube | Intl. Medical Marketing, Inc. | KCQ | Class I | |
| K896559 | Infant Feeding Tube | Westmark, Sterile Packing Systems, Inc. (Sps) | FPD | Class II | |
| K895972 | Curity(r) Percutaneous Catheters | Kendall Healthcare Products Co. Div.Of Tyco Health | DQY | Class II | |
| K895824 | L.t.c. Enteral Bag Administration Set W/pump Set | Intl. Medical Marketing, Inc. | FPD | Class II | |
| K895547 | Grandcor/cardioline Ect Stress Testing | Grandcor Medical Systems | DSI | Class II | |
| K895507 | Link Giebel Blade Plate System | Link America, Inc. | KTT | Class II | |
| K895468 | Orgenics Immunocomb(tm) Chlamydia Trachomatis Igg | Orgenics, Ltd. | LJC | Class I | |
| K895297 | Autotransfusion Reservior Model 7900 Modification | Boehringer Laboratories, LLC | CAC | Class II | |
| K894300 | Submersible Reverse Osmosis Water Purification Sys | U.S. Filter/Continental Water Systems | FIP | Class II | |
| K900891 | Modified Aml + Acetabular Cup Prosthesis | Depuy, Inc. | JDI | Class II | |
| K900795 | Mobilimb L4 Lower Limb Cpm Unit | Toronto Medical Corp. | BXB | Class I | |
| K900506 | Modified Coatron II and Coatron Jr. | Astral Medical Systems | JPA | Class II | |
| K900466 | Mobilimb W1 Wrist Cpm Unit | Toronto Medical Corp. | BXB | Class I |