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 |
|---|---|---|---|---|---|
| K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | NXC | Class II | |
| K253884 | Koios DS (3.8) | Koios Medical, Inc. | POK | Class II | |
| K253704 | iPredict-DR | iHealthscreen, Inc. | PIB | Class II | |
| K253463 | ILR ECG Analyzer (IM007) | Implicity | DQK | Class II | |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | DPS | Class II | |
| K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co | OYX | Class II | |
| DEN250034 | Claria System | Claria Medical | SIM | Class II | |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products Inc. | EBF | Class II | |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Corp. | QJP | Class II | |
| K261852 | OTS Hip | Ortoma AB | OLO | Class II | |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | EBF | Class II | |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | EBI | Class II | |
| K261473 | Chromix | Termosalud S.L. | OHS | Class II | |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co. KG | HRS | Class II | |
| K261021 | EasyWhip Family | Winter Innovations, Inc. | GAT | Class II | |
| K260556 | Veritas Shoulder System | restor3d, Inc. | PHX | Class II | |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | GEI | Class II | |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | |
| K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Medtronic, Inc. | GAG | Class II | |
| K253434 | OSSTM Orthopedic Salvage System | Zimmer GmbH | JDI | Class II | |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K252483 | Enteral Syringe (20ml, 60ml) | Chirana T.injecta, A.S. | PNR | Class II | |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | EIH | Class II | |
| K261808 | ISAAC Neurovascular Navigation Catheter | MicroVention, Inc., d/b/a Terumo Neuro | QJP | Class II | |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems | DQK | Class II | |
| K261101 | Ceribell Monitor | Ceribell, Inc. | OMC | Class II | |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical, Inc. | GEH | Class II | |
| K260576 | MeVis AVM Contour | Mevis Medical Solutions AG | LLZ | Class II | |
| K253767 | UB ERP System | Universal Brain Inc. | OLT | Class II | |
| K261481 | Pangea Femur Reconstruction System | Stryker Corp. | HSB | Class II | |
| K261461 | Omnipod 6 algorithm | Insulet Corporation | QJI | Class II | |
| K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | KIF | Class II | |
| K261052 | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd | OHS | Class II | |
| K260918 | Zolid Lunaris | Amann Girrbach AG | EIH | Class II | |
| K260667 | Alturion Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | Sterilmed Inc | OWQ | Class II | |
| K253969 | Adas 3D | ADAS3D Medical S.L | QIH | Class II | |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | QIH | Class II | |
| K253484 | Lutronic Genius | Cynosure Lutronic Technology Corporation | GEI | Class II | |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan Ltd. | GEI | Class II | |
| K261122 | Mist Ic | Imagine Milling Technologies, LLC | NHA | Class II | |
| K253390 | Somnum (Somnum) | Honeynaps Co., Ltd. | OLZ | Class II | |
| K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | GWF | Class II | |
| K261745 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | DXF | Class II | |
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | DQO | Class II | |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries Inc | GXY | Class II | |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | HRS | Class II | |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | Ziree Co., Ltd. | OAP | Class II | |
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Medical | CGL | Class II |