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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K222926 | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | Shenzhen Yuezhongxing Technology Co.,Ltd | DXN | Class II | |
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. | HQD | Class II | |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | Allwin Medical Devices, Inc. | EZN | Class II | |
| K202963 | ELEC Master, ELEC Master Dual | Mgnewton Ltd. | EIA | Class I | |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Ortho-Clinical Diagnostics, Inc. | QVP | Class II | |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | Ortho-Clinical Diagnostics, Inc. | QVP | Class II | |
| K230994 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | MMI | Class II | |
| K230960 | DLP™ Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | DWF | Class II | |
| K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | Smith & Nephew, Inc. | JWH | Class II | |
| K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | HBE | Class II | |
| K230531 | SOZO Pro | Impedimed, Inc. | QJB | Class II | |
| K230530 | SOZO Pro | Impedimed, Inc. | OBH | Class II | |
| K230340 | Lucas Plus | Amt Engineering Co., Ltd. | GEX | Class II | |
| K230266 | Orchid Safety Release Valve | Linear Health Sciences LLC | QOI | Class II | |
| K230082 | Auto Segmentation | GE Healthcare | QKB | Class II | |
| K223805 | Agnes | Agnes Medical Co.,Ltd | GEI | Class II | |
| K223771 | Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K223756 | SimPro™ Now, GentleCath™ Hydrophilic | Dentsply Sirona Inc | EZD | Class II | |
| K223430 | ProLift Micro Expandable Spacer System | Life Spine | MAX | Class II | |
| K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio de Produtos Medicos | NJM | Class II | |
| K222388 | swiftPro System | Emblation Limited | NEY | Class II | |
| K222097 | OLYMPIC Deformity Band System | Astura Medical | OWI | Class II | |
| K221798 | Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. | DQA | Class II | |
| K220713 | Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | |
| K220322 | Pollogen STOP U Model UXV Device | Pollogen Ltd | PAY | Class II | |
| K220290 | Revitalair 430+ | US Hyperbaric Network LLC | CBF | Class II | |
| K213280 | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App | BD Kiestra B.V. | QQY | Class II | |
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C | Nucleix Ltd. | MMW | Class II | |
| K230948 | BFlex™ 2 Slim 3.8 Single-Use Bronchoscope | Verathon Medical (Canada) ULC | EOQ | Class II | |
| K230938 | ARIX Humerus System | Jeil Medical Corporation | HRS | Class II | |
| K230934 | ViewFlex™ Eco Reprocessed ICE Catheter | Abbott Medical | OWQ | Class II | |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | Signature Orthopaedics Pty Limited | MBI | Class II | |
| K230203 | Dentis I-FIX Abutment | Dentis Co.,Ltd | NHA | Class II | |
| K230123 | Apollo Knotless Suture Anchor | Maruho Medical | MBI | Class II | |
| K223843 | FloPatch FP120 | Flosonics Medical | DPW | Class II | |
| K223758 | Epione | Quantum Surgical SAS | JAK | Class II | |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | KNS | Class II | |
| K212743 | MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System | Medschenker, Inc. | JSM | Class I | |
| K230977 | SIS System | Surgical Information Sciences, Inc. | QIH | Class II | |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | KRA | Class II | |
| K230912 | Artix BG | Inari Medical, Inc. | QEW | Class II | |
| K230880 | CoreLink Navigation Instruments | Corelink, LLC | OLO | Class II | |
| K230614 | Cortium™ | ulrich medical USA Inc | NKG | Class II | |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | QDA | Class II | |
| K230119 | 3D Anatomic Model | Ricoh USA, Inc. | LLZ | Class II | |
| K223907 | NuEra Tight RF Model APMD145.M70-US | Bios S.r.l. | PBX | Class II | |
| K223529 | PressON Spinal Fixation System | Nexus Spine, L.L.C. | NKB | Class II | |
| K223511 | Excella Navigation Instruments | Innovasis, Inc | OLO | Class II | |
| K223495 | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | QSY | Unclassified |