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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K142094 | Copan Fecalswab Collection, Transport and Preservation System | Copan Italia | JSM | Class I | |
| K141932 | Aquios Cl Flow Cytometer, Aquios Tetra-1 Panel,aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios | Siemens Healthcare Diagnostics Inc. | OYE | Class II | |
| K141349 | Disposable sterile needle retractable safety syringe | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | MEG | Class II | |
| K140360 | Health Kiosk | Engagementhealth, LLC | DXN | Class II | |
| K133697 | Breast-Med Tissue Marker | Breast-Med Inc. | NEU | Class II | |
| K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml | Osseon, LLC | NDN | Class II | |
| K150567 | Medtronic Bio-Medicus Cannula Insertion Kit | Medtronic, Inc. | DWF | Class II | |
| K150331 | 18ch T/R Knee Coil | Quality Electrodynamics | MOS | Class II | |
| K150292 | Chocolate PTCA Balloon Catheter | Trireme Medical, Inc. | LOX | Class II | |
| K150183 | ApexM | Incontrol Medical, LLC | KPI | Class II | |
| K150098 | LightStim Professional 2-Panel Light | LED Intellectual Properties LLC | OHS | Class II | |
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | GEX | Class II | |
| K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex GmbH | HTY | Class II | |
| K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | KWT | Class II | |
| K143610 | Bd Intima II Closed IV Catheter | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | EFA | Class I | |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | Halyard Health | PNR | Class II | |
| K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4WEB Inc. | MAX | Class II | |
| K143255 | Prelude SNAP Splittable Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K143253 | O-Mar | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K143008 | Vantage Titan 3T | Toshibamedical Systems Corporation | LNH | Class II | |
| K142581 | APTUS Foot System | Medartis AG | HRS | Class II | |
| K142421 | G-scan Brio | Esaote S.p.A. | LNH | Class II | |
| K142330 | Kobold Ring and Tandem Applicator Set | Kobold, LLC | JAQ | Class II | |
| K142056 | Lioli IOL Delivery System | AST Products, Inc. | MSS | Class I | |
| K141781 | Kogent Spetzler Lighted Suction Tubes | Katalyst Surgical, LLC | HBI | Class II | |
| DEN140039 | NOVA View Automated Fluorescense Microscope | Inova Diagnostics, Inc. | PIV | Class II | |
| K150647 | Polyscrew Pedicle Screw System | New Era Orthopedics, LLC | MNI | Class II | |
| K150634 | AngioSculpt PTA Scoring Baloon Catheters | Spectranetrics | PNO | Class II | |
| K150506 | ELIAN Digital Diagnostic X-ray System | Osko, Inc. | KPR | Class II | |
| K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | DHN | Class II | |
| K150051 | Exilite | BTL Industries, Inc | ONF | Class II | |
| K143400 | SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | KWS | Class II | |
| K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K141737 | Conventus Phs System | Conventus Orthopaedics, Inc. | JDS | Class II | |
| K133033 | Hidrex Psp1000 | Hidrex GmbH | EGJ | Class II | |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | DNK | Class II | |
| K150580 | UltraVision 2 Diagnostic Ultrasound System | Winprobe Corporation | IYO | Class II | |
| K150229 | SOLSTICE OCT System | Life Spine | KWP | Class II | |
| K150172 | ACCLARENT SE Inflation Device | Acclarent Inc | LRC | Class I | |
| K143249 | SOLSTICE OCT System | Life Spine | KWP | Class II | |
| K150738 | VitreaView | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K150400 | Renu Gel | Cytophil, Inc | MIX | Class II | |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | OTO | Class II | |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | OTO | Class II | |
| K143523 | Airlock osteosynthesis plate system | Novastep | HRS | Class II | |
| K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K143385 | Acumed Ankle Plating System | Acumed LLC | HRS | Class II | |
| K143077 | Trevo XP ProVue Retriever (6X25mm) | Concentric Medical, Inc. | NRY | Class II |