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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | |
| K180807 | Celling Aspiration Needle | Spine Smith Partners L.P. | KNW | Class II | |
| K180756 | Safety Wire Guide Introducer | Cook Incorporated | EZN | Class II | |
| K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K180414 | EPX-4440FN Digital Video Processor with Light Source | Fujifilm New Development U.S.A., Inc. | FET | Class II | |
| K173938 | IS-III HActive Fixture | Neobiotech Co., Ltd. | DZE | Class II | |
| K172708 | T2Bacteria Panel | T2biosystems, Inc. | QBX | Class II | |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords | Wilson-Cook Medical Inc./Cook Endoscopy | KNS | Class II | |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern | Euroimmun US Inc. | MOB | Class II | |
| K170697 | GBR system | Surgident Co., Ltd. | JEY | Class II | |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | QBS | Class II | |
| K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | HRS | Class II | |
| K181059 | geko T-3 Neuromuscular Stimulator | Firstkind Ltd | IPF | Class II | |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. | JIL | Class II | |
| K180811 | Biograph Vision | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K180609 | Rodo Smilekey | Rodo Medical, Inc | NHA | Class II | |
| K180403 | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K180201 | Route 92 Medical Access System | Route 92 Medical, Head Quarters | DQY | Class II | |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | ODP | Class II | |
| K180808 | Omni Foot Plating System | Extremity Medical, LLC | HRS | Class II | |
| K180773 | Reusable and Self-Adhesive Electrodes | Shaoxing Dongzhi Electrical Technology Co., Ltd. | GXY | Class II | |
| K180662 | Arthrex FastThread Interference Screw | Arthrex GmbH | MAI | Class II | |
| K180455 | NeuralBot | Neural Analytics, Inc. | IYN | Class II | |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | GWG | Class II | |
| K173862 | Pantheris System | Avinger, Inc. | MCW | Class II | |
| K173405 | DiLumen Endolumenal Interventional Scissors (DiLumen Is) | Lumendi, LLC | GEI | Class II | |
| K180817 | AERIAL™ Interspinous Fixation | Globus Medical, Inc. | PEK | Class II | |
| K180545 | VACUETTE SAFELINK Holder with male luer lock | Greiner Bio-One Na, Inc. | FMI | Class II | |
| K180220 | SAGICO OSI Spinal System by Osimplant | Spinal Analytics & Geometrical Implant Co, LLC | NKB | Class II | |
| K180197 | Erchonia FX-635 | Erchonia Corporation | NHN | Class II | |
| K173956 | Biowy PlCC Catheter | Biowy Corporation | LJS | Class II | |
| K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch | Fresenius Medical Care Renal Therapies Group, LLC | KDJ | Class II | |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.p.A. | JAA | Class II | |
| K172729 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | FDI | Class II | |
| K181179 | BrainScope One | Brainscope | PIW | Class II | |
| K181145 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | |
| K180908 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan Ltd. | GEI | Class II | |
| K180886 | Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL | Liofilchem S.r.l. | JWY | Class II | |
| K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | HRX | Class II | |
| K180771 | Acro HCG Pregnancy Rapid Test | ACRO BIOTECH Inc. | LCX | Class II | |
| K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA Inc | NDN | Class II | |
| K180663 | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM | Livermoretech,Inc | KPR | Class II | |
| K180524 | EEG-Now | Encephalodynamics, Inc. | GXY | Class II | |
| K180508 | Joule System | Sciton, Inc. | GEX | Class II | |
| K180460 | Theradome LH40 | Theradome, Inc. | OAP | Class II | |
| K180375 | The IQoolTM Warm System | Braincool AB | DWJ | Class II | |
| K180259 | Sterile Hypodermic Needle for Single Use | Jiangsu Shenli Medical Production Co., Ltd. | FMI | Class II | |
| K180217 | VESTEX Apparel | Vestagen Protective Technologies, Inc. | QBW | Class II | |
| K180087 | A.M. Surgical Intramedullary Fixation Device | A.M. Surgical, Inc. | HTY | Class II | |
| K180051 | XSTAT 30, 1-Pack | Revmedx Inc | PGZ | Class II |