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 |
|---|---|---|---|---|---|
| K980811 | Seraquest Anti-Sm/rnp | Quest Intl., Inc. | LKP | Class II | |
| K980810 | Seraquest Anti-Ssa | Quest Intl., Inc. | LJM | Class II | |
| K980726 | Ultra-Blaster | Ultradent Products Inc. | KOJ | Class II | |
| K980671 | Coloscreen-Es | Helena Laboratories, Corp. | KHE | Class II | |
| K980530 | Peregrine Fiber Optic Bipolar Straight Pick and Angled Pick, Models Pd100.12 and Pd100.13 | Peregrine Surgical, LLC. | MPA | Class II | |
| K980337 | Diamedix Immunosimplicity Ana (Is-Ana) Screen Test System | Helix Diagnostics, Inc. | LJM | Class II | |
| K980076 | Premier Platinum Hpsa | Meridian Diagnostics, Inc. | LYR | Class I | |
| K974196 | Megavac System | Barry J. Kaplan, Inc. | LKY | Class II | |
| K973922 | Archimed 4210 and 4220 | Esaote North America, Inc | LOS | ||
| K973820 | USA Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode | Circon Corp. | FAS | Class II | |
| K971408 | Sevrain Cranial Clamp (Scc-200 Series) | Ikonos Corp. | GXN | Class II | |
| K981516 | Sterngold Implamed Hex Screw Implant Tps Coated Sterngold Implamed Hex Screw Implant Ha Coated , Refer to Table 1 in Sub | Sterngold/Implamed | DZE | Class II | |
| K981392 | Elite Mark IV Powder Free Polyurethane Synthetic Surgical Glove | Ansell Perry | KGO | Class I | |
| K981372 | Synthes 3.0 Mm Pc-Fix System | Synthes (USA) Products LLC | HWC | Class II | |
| K981327 | Interacoustics Model Ad226 Diagnostic Audiometer | Idem (Int'L Dist. of Electronics for Medicine) | EWO | Class II | |
| K981259 | Osteo 4.0Mm Cannulated Screw System | Osteonics Corp. | HWC | Class II | |
| K981128 | Sofsilk Suture | United States Surgical, A Division of Tyco Healthc | GAP | Class II | |
| K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) | TORNIER Inc. | GAB | Class I | |
| K980986 | Procad | Ivoclar USA, Inc. | EIH | Class II | |
| K980963 | Honigum Automix Impression Material (Foil Bags) and Honigum Quick Impression Material (Cartridges) | Foremost Dental Mfg., Inc. | ELW | Class II | |
| K980958 | Hakomed Elecdt/vacupulls | Alive, Inc. | IPF | Class II | |
| K980942 | Regent Biogel Indicator Inner Surgical Glove | London International Group, Inc. | KGO | Class I | |
| K980928 | Synthes Spine Universal Spinal Hook, Rod, Pedicle/sacral Screw Fixation System | Synthes GmbH | KWP | Class II | |
| K980892 | Hakomed Elecdt / Pro Eledt Series | Alive, Inc. | IPF | Class II | |
| K980863 | Dumex Pak-Its Non-Woven Dressing Impregnated Sith Sodium Chloride (Hypertonic) | Dumex Medical Surgical Products, Ltd. | KMF | Class I | |
| K980844 | Surgidev Silicone Punctum Plug | Advanced Vision Science, Inc. | LZU | Unclassified | |
| K980809 | Lumiscan 135 Phosphor Plate Digitizer/lumisys 135 Eraser | Lumisys, Inc. | LMA | Class II | |
| K980741 | Boston Eo Rigid Gas Permeable Contact Lens Material (Enflofocon B) | Polymer Technology Div. Wilmington Partners, L.P. | HQD | Class II | |
| K980704 | Safil Synthetic Absorbable Surgical Suture | Aesculap Inc | GAM | Class II | |
| K980691 | Airis Magnetic Resonance Diagnostic Device | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K980645 | Philips Gyroscan Nt Release 6 Series | Philips North America LLC | LNH | Class II | |
| K980624 | Cardiostation | Universal Medical, Inc. | DXH | Class II | |
| K980595 | Depuy Orthotech Catera Suture Anchor | Depuy Orthopaedics Inc. | MBI | Class II | |
| K980512 | Lorenz Reconstruction System with Modular Screw | Biomet Microfixation | JEY | Class II | |
| K980065 | c/t Med-Systems Cassette System | C/T Med System, Ltd. | KCT | Class II | |
| K980021 | Extentrac | Advanced Back Technologies | JFB | Class II | |
| K974560 | Cordis Vanguard Steerable Guidewires | Cordis US Corp. | DQX | Class II | |
| K974038 | The Aspirator, 6Ft Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene Stopper, Angled Tube Mounts, Foot | A & A Medical, Inc. | JCX | Class II | |
| K973955 | Herniamesh Surgical Meshes | Herniamesh SRL | FTL | Class II | |
| K973561 | Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12Cm, Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 1M | Medical Components, Inc. | FOZ | Class II | |
| K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | IYO | Class II | |
| K981505 | Cozumel Diagnostic Ultrasound System | FUJIFILM SonoSite,Inc. | IYO | Class II | |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) Reagent | Beckman Instruments, Inc. | DKB | Class II | |
| K980808 | Endo Fms Urology | Future Medical Systems, Inc. | LJH | Class II | |
| K980694 | Ksea Plastic Trocars | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K980577 | Princess Syringe | Sodexco | EIA | Class I | |
| K981474 | Cardiac Status Controls (Ck-Mb/myoglobin/troponin I) | Spectral Diagnostics, Inc. | JJY | Class I | |
| K981472 | Drager-Vapor 19.1 W/plug System S Plus | Draeger, Inc. | CAD | Class II | |
| K981305 | Olympus Serum Protein Multicalibrator | OLYMPUS Corporation of the Americas | JIX | Class II | |
| K981189 | Uric Acid | Abbott Medical | CDO | Class I |