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 |
|---|---|---|---|---|---|
| K000964 | Sterile Water or O.9% Sodium Chloride, Model Al4100 & Al4109 | Automatic Liquid Packaging, Inc. | JOH | Class II | |
| K000762 | Moxifloxacin, 5 Ug, Bbl Sensi-Disc | BD Becton Dickinson Vacutainer Systems Preanalytic | JTN | Class II | |
| K000649 | Sysmex Automated Coagulation Analyzer, Model Ca-1500 | Siemens Healthcare Diagnostics Inc. | GGP | Class II | |
| K000255 | Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator | LivaNova USA, Inc. | DTZ | Class II | |
| K992597 | Lorad Lt-100 Laser Treatment System | Focus Medical, LLC. | GEX | Class II | |
| K001133 | Vitro Chemistry Products Eco2 Slide & Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | KHS | Class II | |
| K001105 | Moss Miami 6.35Mm Rod System Pedicle and Laminar Hooks | Depuyacromed | KWP | Class II | |
| K001016 | Ge Logiq 700 | GE Healthcare | ITX | Class II | |
| K000985 | Matang Powdered Latex Patient Examination Glove with Protein Labeling Claim (50 Microgram or Less | Matang Mfg. Sdn. Bhd. | LYY | Class I | |
| K000612 | Accucore Single Action Core Biopsy Device | Inrad | KNW | Class II | |
| K000557 | Medvizer Pacs, Model Release 2000 | Vitel Net | LLZ | Class II | |
| K000496 | Evershears Bipolar Scissors | Everest Medical Corp. | GEI | Class II | |
| K000452 | Screeners Methamphetamine Test, Drugscreen Dip Methamphetamine Test | Drug Detection Devices, Ltd. | LAF | Class II | |
| K000443 | Remote Fetal Medicine Ultrasound System | R4 Telemedicine, Inc. | LLZ | Class II | |
| K000432 | Response 2000 Cemented Hip Stem | Depuy Orthopaedics Inc. | LZO | Class II | |
| K000412 | Vision r/f Tilting Table | Villa Sistemi Medicali S.p.A. | IXR | Class II | |
| K000392 | Response 2000 Hip Stem | Depuy Orthopaedics Inc. | LZO | Class II | |
| K000297 | Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod. Erchinger | Erchinger Medizintecnik | FHN | Class II | |
| K993871 | Bioshield Heavy Duty and Super Duty Express Sterilization Wrap | Medtronic, Inc. | FRG | Class II | |
| K993492 | Devilbiss Nebulizer Model 800 | Sunrise Medical Hhg, Inc. | CAF | Class II | |
| K001189 | Modification to Convertors Surgical Gowns | Medtronic, Inc. | FYA | Class II | |
| K001131 | 3D Hdraulic Fine Micromanipulator Mo-188Ne | Narishige Co., Ltd. | MQJ | Class II | |
| K001130 | 3D Manual Coarse Manipulator Mn-188Ne | Narishige Co., Ltd. | MQJ | Class II | |
| K001123 | Kurz Upper Eyelid Implant Sizers, Model 8000 111 | Heinz Kurz GmbH Medizintechnik | MML | Class II | |
| K000956 | Modification to Scimed 6F Impulse Angiographic Cathaters | Boston Scientific Corporation | DQO | Class II | |
| K000867 | Powder Free Latex Examination Gloves, Peppermint Scented (Contains 50 Mcgm or Less of Total Water Extractable Protein Gr | Sgmp Co., Ltd. | LYY | Class I | |
| K000507 | Cavermap Surgical Aid | Uromed Corp. | ETN | Class II | |
| K000444 | Mityview 4-Way Lateral Expander Speculum | Prism Enterprises, Inc. | HIB | Class II | |
| K000212 | Ksea Chardonnes Morcellation Knife | Karl Storz Endoscopy-America, Inc. | KOH | Class I | |
| K994174 | Frialit-2 Mh-2 Abutment | Friadent GmbH | DZE | Class II | |
| K993356 | Coulter Hematology Analyzers with Irf & Mrv Analyses | Coulter Corp. | GKZ | Class II | |
| K992732 | Sterile Water & Sterile 0.9% Sodium Chloride | Dumex Medical Surgical Products, Ltd. | FOZ | Class II | |
| K001102 | Parset Primary Set with Check Valve, Model A10002e | Rd Medical Mfg., Inc. | FPA | Class II | |
| K000962 | Pico Smokerlyzer, Model Ec-50 | Bedfont Scientific Ltd. | CCJ | Class II | |
| K000953 | Disposable Powdered Vinyl Synthetic Exam Gloves, White Color | Shanghai Antares Industries, Inc. | LYZ | Class I | |
| K000875 | Assayed Qcs 1,2, Cat. Nos. 970200, 970500 | Bio-Rad | JJY | Class I | |
| K000868 | Non-Sterile Powder-Free, Blue Nitrile Examination Gloves | Sgmp Co., Ltd. | LZA | Class I | |
| K000650 | Betel Powder Free Latex Exam Gloves | Betel Care Sdn. Bhd. | LYY | Class I | |
| K000549 | Opart, Model Mrt-600 | Toshiba America Mri, Inc. | MOS | Class II | |
| K000448 | Pacsstation | Fernandez Industries, Inc. | LLZ | Class II | |
| K000247 | Bausch & Lomb Renu 1 Step Daily Protein Remover | Bausch & Lomb Incorporated | LPN | Class II | |
| K000195 | Cranial Drill | Image-Guided Neurologics, Inc. | HBB | Class II | |
| K993268 | Mallinckrodt Dar Heated Wire Breathing Circuit | Mallinckrodt Dar S.r.l. | BTT | Class II | |
| K992294 | Bioceramic Orbital Implant | Fci Ophthalmics, Inc. | HPZ | Class II | |
| K991380 | Oil for Tissue Culture | Advanced Reproductive Technologies | MQL | Class II | |
| K001025 | Lifecard Cf Compact Recorder | Reynolds Medical, Ltd. | DSH | Class II | |
| K000961 | Aaron 900 High Frequency Dessiccator/handpiece | Apyx Medical Corporation | GEI | Class II | |
| K000936 | Vapr 2.3Mm Wedge Electrode for Use with Vapr System | Mitek Products | GEI | Class II | |
| K000516 | Ge Logiq 700 | GE Healthcare | IYO | Class II | |
| K000478 | The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1 | Accuray Incorporated | IWB | Class II |