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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K800761 | Point to Point Level | Radiation Products Design, Inc. | IYE | Class II | |
| K800759 | Elev. Back Support W/adj. Arm Positioner | Radiation Products Design, Inc. | IYE | Class II | |
| K800723 | Micro-Coil 100 Coil Dialyzer | Erika, Inc. | FHS | Class II | |
| K800710 | Ferritiron Kit Cat. #Rp-1100 | Ria Products, Inc. | JQG | Class I | |
| K800652 | Model E03 Echo-Opthalmoscope | Kt Medical, Inc. | IYO | Class II | |
| K800639 | Orbitor | Philips North America LLC | JAA | Class II | |
| K800629 | Intravenous Infusion Pump, Code 2M8015 | Travenol Laboratories, S.A. | FRN | Class II | |
| K800382 | Clear-View Mirror Warmer | Surgical Mechanical Research, Inc. | GET | Class I | |
| K790755 | Smec Balloon Cannula | Smec, Inc. | DSP | Class II | |
| K800997 | Digoxin Clasp Ria Kit | E. R. Squibb & Sons, Inc. | LCS | Class II | |
| K800992 | Cordia Np | Cordis US Corp. | DHC | Class II | |
| K800991 | Cordia N | Cordis US Corp. | DHC | Class II | |
| K800990 | Trach Mist Unit W/or without Elbow | Airlife, Inc. | BYH | Class I | |
| K800976 | M.r. Assoc. W Type Grasping Forceps | Mr Associates, Inc. | OCZ | Class II | |
| K800975 | M.r. Assoc. True-Feel Handle | Mr Associates, Inc. | KNS | Class II | |
| K800974 | M.r. Assoc. Power Cord | Mr Associates, Inc. | KNS | Class II | |
| K800973 | M.r. Assoc. Hot Biopsy Forceps | Mr Associates, Inc. | KNS | Class II | |
| K800972 | M.r. Assoc. Tripod Grasping Forceps | Mr Associates, Inc. | OCZ | Class II | |
| K800971 | M.r. Assoc. Magnetic Extractor | Mr Associates, Inc. | FCC | Class II | |
| K800970 | M.r. Assoc. Basket Retrievers | Mr Associates, Inc. | OCZ | Class II | |
| K800969 | M.r. Assoc. Cannulas | Mr Associates, Inc. | OCZ | Class II | |
| K800968 | M.r. Assoc. Rat Tooth Grasp Forceps | Mr Associates, Inc. | OCZ | Class II | |
| K800967 | M.r. Assoc. Alligator Graspong Forceps | Mr Associates, Inc. | OCZ | Class II | |
| K800966 | M.r. Assoc. Cytology Brushes | Mr Associates, Inc. | FDX | Class II | |
| K800965 | M.r. Assoc. Snares; Crescent Snare Wire | Mr Associates, Inc. | KNS | Class II | |
| K800964 | M.r. Assoc. Ball Type Coagulator | Mr Associates, Inc. | KNS | Class II | |
| K800963 | Biopsy Forceps W/needle M.r. Assoc. | Mr Associates, Inc. | FCL | Class I | |
| K800962 | M.r. Assoc. Washing Tube/measuring Tube | Mr Associates, Inc. | ODC | Class II | |
| K800951 | Casta-Lloy | U.S. Shizai Corp. | EJS | Class II | |
| K800948 | Doodle Brush | Lawton Surgical Instruments | |||
| K800945 | Radioear Model Rei Hearing Aid | Radioear Corp. | ESD | Class I | |
| K800943 | Pentex Bovine Albumin 30% Solution | Miles Laboratories, Inc. | KSG | Class II | |
| K800942 | Volu-Sol Eosin Y Stain | Volu Sol Medical Industries | HYB | Class I | |
| K800938 | Tri-Check | Scientific Standards, Inc. | JPK | Class II | |
| K800926 | Thromboquik Thrombin Reagent Prod. #3551 | General Diagnostics | GJA | Class II | |
| K800919 | Oraview by Water Pik | Teledyne, Inc. | EAX | Class I | |
| K800916 | P1 Blood Group Substance | Travenol Laboratories, S.A. | KSX | Class II | |
| K800914 | No-Boil Folate Kit #Rp-500 | Ria Products, Inc. | CGN | Class II | |
| K800905 | Siemens-Elema Ab O2-Air Mixer 960 | Siemens Elema AB | BZR | Class II | |
| K800897 | Rid System-Quad Multitest Igg, Iga,etc. | Icl Scientific | DEW | Class II | |
| K800881 | Disposable Berman Airways | Harvard Laboratories | CAE | Class I | |
| K800874 | Pelvic Exam Tray | Pharmaseal Laboratories | HHD | Class I | |
| K800873 | Time Steam Autoclave Tape | Professional Tape Co., Inc. | JOJ | Class II | |
| K800849 | Tms 1000 Temp. Monitor & Probes | Gics Pharmaceuticals | FLL | Class II | |
| K800847 | Entellan | Mcb Manufacturing Chemists, Inc. | KEP | Class I | |
| K800831 | Py-Co-Prox Tm Dental Brush | Block Drug Company, Inc. | EFW | Class I | |
| K800829 | Myerson R&kenson R Porcelain Ant&pos.- | Myerson Tooth Corp. | ELL | Class II | |
| K800786 | Injection Site, Code No. 3100 | Quest Medical, Inc | FOZ | Class II | |
| K800755 | Boehringer Labs Ambulatory PEEP Valve | Boehringer Laboratories, LLC | BYE | Class II | |
| K800751 | Radx Vent-Al Mechanical Resporator | Radx Corp. | KPX | Class II |