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 |
|---|---|---|---|---|---|
| K081070 | Interlace Medical Operative Hysteroscopy System | Interlace Medical, Inc. | HIH | Class II | |
| K080841 | Cosmic System | Ulrich GmbH & Co. KG | MNI | Class II | |
| K080512 | Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue Visibility Tint | Metro Optics of Austin, Inc. | LPL | Class II | |
| K080463 | Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories | Alma Lasers Ltd. | GEX | Class II | |
| K080212 | Medela Thopaz, Model 200 0288 | Medela AG | BTA | Class II | |
| K073616 | Fas-Clean Electrosurgical Coated Active Blade | Electromedics, Inc. | GEI | Class II | |
| K073246 | Zenieva | Gorbec Pharmaceutical Services, Inc. | NAE | Class I | |
| K073159 | Trauson Bone Screw, Models Ha 3.5 and 4.5 | Trauson (Jiangsu) Medical Instrument Co., Ltd. | HWC | Class II | |
| K063841 | Nmr Profiler and Nmr Lipoprofile Assay, Controls | Liposcience | MRR | Class I | |
| K081916 | Ge Signa Mr Oncology Package | GE Healthcare | LNH | Class II | |
| K081776 | Continuous Cardiac Ouput Monitor, Truccom | Omega Critical Care Limited | DXG | Class II | |
| K081677 | Savi Applicator Kit | Cianna Medical, Inc. | JAQ | Class II | |
| K081407 | Orthopediatrics Pediplates System | Orthopediatrics Corp | HRS | Class II | |
| K081323 | Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 | BK Medical ApS | FCG | Class II | |
| K081227 | Plexur M | Osteotech Inc | MQV | Class II | |
| K081184 | Gore Viabil Bililary Endoprosthesis | W.L. Gore & Associates, Inc. Medical Products Div. | FGE | Class II | |
| K081171 | Tritanium Acetabular Shell System | Howmedica Osteonics Corp | LPH | Class II | |
| K081157 | Accuframe | Cagenix, Inc. | NHA | Class II | |
| K073057 | Pulsar Generator, Model Ps100-100, and Peak Plasmablade Tissue Dissection Device, Model Ps200-040 | Peak Surgical, Inc. | GEI | Class II | |
| K081655 | Powder Free Vinyl Patient Examination Gloves (Light Yellow) | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | |
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2uvc4.0, S2uvc5.0 | Halyard Health | FOS | Class II | |
| K081249 | Dimension Vista System A2mac Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem | Siemens Healthcare Diagnostics Inc. | DEB | Class II | |
| K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing | Abbott Medical | JKA | Class II | |
| K081218 | Bellystep, Headstep, Breaststep, Prostep, Wingstep and Icast | It-V Medizintechnik, GmbH | IYE | Class II | |
| K080864 | Cam Structsure Precision Milled Bars | ZimVie US Corp LLC | NHA | Class II | |
| K080862 | Sonicweld Rx (Resorb-X) | KLS-Martin L.P. | JEY | Class II | |
| K080341 | Endodrape(tm) | Vortek Surgical, LLC | KKX | Class II | |
| K080252 | Modification to Mammaprint | Agendia Inc | NYI | Class II | |
| K073030 | Ag-605 Blood Glucose Monitoring System | Andon Health Co., Ltd | NBW | Class II | |
| K063662 | Ramp Nt-Probnp Assay | Response Biomedical Corp. | NBC | Class II | |
| K081950 | Progenix Plus | Medtronic Sofamor Danek | NUN | Class II | |
| K081719 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System | Stanbio Laboratory | GKR | Class II | |
| K081631 | Sintea Biotech Pls Multi-Axial Screws | Sintea Biotech, Inc. | MNH | Class II | |
| K081619 | Chromolite Ep | Chromogenex Technologies Limited | GEX | Class II | |
| K081531 | Aoc Soluble Implant Material | Ceremed, Inc. | KHJ | Class II | |
| K081513 | Merete 3.0 and 3.5 Mm Locking Screws | Merete GmbH | HWC | Class II | |
| K081512 | Stealthviz Advanced Planning Application with Stealthdti Package | Medtronic Navigation, Inc | LLZ | Class II | |
| K081452 | Synthes (USA) Stainless Steel Elastic Intramedullary Nail System | Synthes (USA) Products LLC | HSB | Class II | |
| K081402 | Simplant Ortho ; Vistadent 3D | Materialise Dental NV | LLZ | Class II | |
| K081288 | Aspira Peritoneal Drainage System | C.R. Bard Inc | PNG | Class II | |
| K081284 | Variax Distal Fibula Plate | Howmedica Osteonics Corp | KTT | Class II | |
| K081208 | Cinch Anchor, Model 1194 | Abbott Medical | GZB | Class II | |
| K081156 | Cadd Medication Cassette Reservoir | Abbott Medical | FPA | Class II | |
| K081061 | Harvard Medical Devices Ir Ear Thermometer, Models Hmiret-002 and Kinetik Branded Iet1 Series | Harvard Medical Devices, Ltd. | FLL | Class II | |
| K080875 | Pigalileo 4Th Generation System | Smith & Nephew, Inc. | HAW | Class II | |
| K080807 | Blood Tubing Sets (Sterile Fluid Path) | NxStage Medical Inc | FJK | Class II | |
| K080583 | Modified Hd Guide Catheter | Concentric Medical, Inc. | DQY | Class II | |
| K080465 | Ws Far Infrared Therapy Unit, Model # Ty-101 Series | Ws Far IR Medical Technology Co., Ltd. | ILY | Class II | |
| K080125 | Apolowako T-Cho, Hdl-C, Tg and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201 | FUJIFILM Healthcare Americas Corporation | LBS | Class I | |
| K080067 | Iscience Interventional Ophthalmic Microcatheter | Iscience Interventional | MPA | Class II |