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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K232381 | LOGIQ Totus | GE Healthcare | IYN | Class II | |
| K232273 | RM Electrode (RMH 23-01) | Retmap, Inc. | HLZ | Class II | |
| K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | DZE | Class II | |
| K231515 | MySpine Cervical Guides | Medacta International SA | QSD | Class II | |
| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | DWF | Class II | |
| K231127 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K230137 | Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC | FRG | Class II | |
| K233597 | Sonosite LX Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | MXD | Class II | |
| K233521 | Qt ECG (Qterd100) | QT Medical, Inc | DXH | Class II | |
| K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | JAK | Class II | |
| K233042 | Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shandong Intco Medical Products Co Ltd | LZA | Class I | |
| K232769 | BeaMed Laser Surgery Fibers | Bt Beamedical Tachnoogies Ltd. (Beamed) | GEX | Class II | |
| K232206 | SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | GXD | Class II | |
| K231465 | Q-Pad Test System | Qurasense, Inc. | LCP | Class II | |
| K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K230712 | SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. | QRK | Class II | |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical, LLC | OMP | Class II | |
| K222930 | Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing LLC | MRN | Class II | |
| K233568 | Ceevra Reveal 3+ | Ceevra, Inc. | QIH | Class II | |
| K233490 | SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | Bioventus LLC | MQV | Class II | |
| K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | KDI | Class II | |
| K232814 | Electronic Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. | DXN | Class II | |
| K232440 | Adravision Perio | Adra Corporation | QIH | Class II | |
| K232434 | BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit | BD | PSZ | Class II | |
| K232220 | SS Abutment System | OSSTEM Implant Co., Ltd. | NHA | Class II | |
| K231923 | Liberty SI Lateral Implant System | Spinal Simplicity, LLC | OUR | Class II | |
| K231615 | Disposable Endoscopic Bipolar | Jiangsu Hope Biomedical Science&Technology Co.,Ltd. | GEI | Class II | |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics Inc. | HKI | Class II | |
| K231005 | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 | Supermax Healthcare Canada – Supermax Medical | FXX | Class II | |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) | Precision Healing, LLC | QJF | Class II | |
| K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. | DXN | Class II | |
| K222057 | Thermoclick | T&R Biofab Co.,Ltd. | FLL | Class II | |
| K233347 | Verruca-Freeze® H | Cryosurgery, Inc. | GEH | Class II | |
| K232932 | Intense Pulse Light Therapeutic Apparatus | Shenzhen Greatro Electronic Technology Co., Ltd. | OHT | Class II | |
| K232693 | Tyber Medical Distal Radius Plating System | Tyber Medical | HRS | Class II | |
| K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | GXZ | Class II | |
| K232308 | Monarch Blood Collection Set | The Monarch Company, LLC | JKA | Class II | |
| K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | BZR | Class II | |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | JDR | Class II | |
| K230648 | Access hsTnI | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems Inc | QWR | Class II | |
| K220525 | RESPONDER Polysaccharide Hemostat | Starch Medical Inc. | QSY | Unclassified | |
| DEN230045 | Sonu | Sound Health Systems, Inc. | QZC | Class II | |
| K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | DRF | Class II | |
| K233529 | BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories | Lumenis Ltd | GEX | Class II | |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K233149 | CATHTONG III Tapered PICC Catheter | L & z US, Inc. | LJS | Class II |