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 |
|---|---|---|---|---|---|
| K071057 | Colonic & Enema Nozzle | Tiller Mind Body, Inc. | KPL | Class II | |
| K070856 | ICU Medical Single-Use Syringe | Abbott Medical | FMF | Class II | |
| K070788 | Elecsys Cortisol Test System | Roche Diagnostics GmbH | NHG | Class II | |
| K070769 | Vhp 136 Tray | STERIS Corporation | KCT | Class II | |
| K070592 | Small Bone Wedge | Wrightmedicaltechnologyinc | HRS | Class II | |
| K070443 | Intracept Bi-Polar RF Probe, Model 04814 | Relievant Medsystems | GEI | Class II | |
| K070354 | Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) | International Medical Development, Inc. | BSP | Class II | |
| K063631 | Polyperf / Polyperf Safe | Laboratoires Perouse | FPA | Class II | |
| K063131 | Carbamazepine, Valproic Acid, Tdm Calibration Set B and Abtrol, Nortrol Controls | Thermo Electron Oy | KLT | Class II | |
| K072589 | Tapered Screw-Vent Implant, 4.1Mm, Models: Tsv4b8, B10, B11, B13 and B16, Tsv4h8, H11, H13 and H16 | ZimVie US Corp LLC | DZE | Class II | |
| K072507 | Endowave Infusion System | Ekos Corp. | QEY | Class II | |
| K072465 | Niko Corpectomy Spacer | Globus Medical, Inc. | MQP | Class II | |
| K072299 | Powrsyringe Aspirator | Pinyons Medical Technology, Inc. | FMF | Class II | |
| K072024 | Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693 | Nipro Medical Corporation | FJK | Class II | |
| K071740 | Chlorinated Powder Free Nitrile Latex Examination Gloves | Medtexx Manufacturing Sdn. Bhd. | LZA | Class I | |
| K071681 | Cytomics Fc 500 Mpl Flow Cytometer, Model # 626554 | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K071527 | Pneupac Vr1 Air Mix | Abbott Medical | BTL | Class II | |
| K071421 | Promepla Intravascular Administration Set and Extension Set | Promepla | FPA | Class II | |
| K071398 | Scanview, Model Sc-300 | Applied Spectral Imaging, Ltd. | JOY | Class II | |
| K070798 | Adapters for CT, Angiographic, And/or MRI Power Injectors | Coeur, Inc. | DXT | Class II | |
| K070502 | Radius Snare | Radius Medical Technologies, Inc. | DQY | Class II | |
| K062297 | Vhp 136 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | |
| K072665 | Suniray 5.2 | Orangedental GmbH & Co. KG | LLZ | Class II | |
| K072630 | Foru, Model Eq30 | Kwang Yang Motor Co., Ltd. | INI | Class II | |
| K072512 | Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply) | GE Healthcare | FMZ | Class II | |
| K072424 | Cooltouch, Model Lc215,coollipo | New Star Lasers, Inc. | GEX | Class II | |
| K072342 | Sultan Tooth Root Desensitizer | Dentsply International, Inc. | LBH | Class II | |
| K072148 | Ciaglia Blue Dolphin (Tm) Balloon Percutaneous Tracheostomy Introducer | Cook Inc. | JOH | Class II | |
| K072051 | Novatome, Model: Su101-50 | Scholten Surgical Instruments, Inc. | DWZ | Class II | |
| K072039 | Advocate Redi-Code Blood Glucose Monitoring System, Models Td-4223E; Td-4223F | Taidoc Technology Corporation | NBW | Class II | |
| K072008 | Braemar Er900 Wireless Series Arrhythmia Event Recorder | Braemar Manufacturing, LLC | DRG | Class II | |
| K071580 | Ast/got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol | Thermofisher Scientific Oy | CIT | Class II | |
| K071516 | Inomax Ds | Mallinckrodt Manufacturing LLC | MRN | Class II | |
| K071230 | Apnea Risk Evaluation System (Ares), Model 600 | Advanced Brain Monitoring, Inc. | MNR | Class II | |
| K071085 | E3-80 Portable ECG Recorder & Analyzer | Micro-Star International Co., Ltd. | MWJ | Class II | |
| K070296 | Visiolite Ophthalmic Er: Yag Laser System | Ace Vision Group | GEX | Class II | |
| K072606 | Aquilion One Tsx-301A/2 Computed Tomography System | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K072126 | Habib Veseal | Emcision, Ltd. | GEI | Class II | |
| K071799 | Modification to Biostar Oia Shigatox | Iverness Medical Professional Diagnostics | GNA | Class I | |
| K070059 | Reprocessed Trocars | Stryker Sustainability Solutions | NLM | Class II | |
| K072624 | Astra Tech Implant System, New Component | Astra Tech, Inc. | NHA | Class II | |
| K072468 | Modification to D-Spect Cardiac Scanner System | Spectrum Dynamics, Ltd. | KPS | Class II | |
| K072171 | Gatect-Rt | Vision Rt Inc | IYE | Class II | |
| K071938 | Monaco Rtp System | Elekta Limited | MUJ | Class II | |
| K071480 | Liaison 25 Oh Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602 | Diasorin Inc. | MRG | Class II | |
| K071397 | Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series | Sunrise Medical, Inc. | CAW | Class II | |
| K070411 | Amsure Nebulizer | Amsino International, Inc. | CAF | Class II | |
| K063035 | Sleuth Implantable ECG Monitoring System | Transnoma Medical, Inc. | MXC | Class II | |
| K072429 | Modification to Tsrh Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K072069 | Spacer | Vericom Co., Ltd. | EBF | Class II |