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 |
|---|---|---|---|---|---|
| K250027 | Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd | INI | Class II | |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | EBG | Class II | |
| K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | EIH | Class II | |
| K243916 | Primus Spinal Fixation System | Spinal Elements, Inc | NKB | Class II | |
| K243640 | Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. | HIS | Class II | |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise N.V. | DZJ | Class II | |
| K243614 | Sonio Suspect | Sonio | POK | Class II | |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | FRG | Class II | |
| K243330 | LYMA Laser PRO | Lyma Life Ltd. | OHS | Class II | |
| K243278 | Custom Abutments | Straumann USA, LLC | NHA | Class II | |
| K243258 | Paradigm System | Proprio | OLO | Class II | |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | |
| K243088 | Green X 12 SE (PHT-40CHS) | Vatech Co., Ltd. | OAS | Class II | |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | FRG | Class II | |
| K242850 | Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K242838 | QuickRad | Aikenist Technologies Pvt, Ltd. | LLZ | Class II | |
| K242607 | ScanDiags Ortho L-Spine MR-Q | Scandiags AG | QIH | Class II | |
| K241983 | Fassier-Duval Telescoping IM System | Orthopediatrics Canada ULC | HSB | Class II | |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | KTT | Class II | |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | Class II | |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | LYC | Class II | |
| K250487 | SparkTM Clear Aligner System | Ormco Corporation | NXC | Class II | |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Edan Instruments, Inc. | IYN | Class II | |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | JOJ | Class II | |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | ODC | Class II | |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. | NGL | Class II | |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex GmbH | JDQ | Class II | |
| K243312 | Cer-S | Cardiocalm SRL | DQK | Class II | |
| K243283 | Alinity h-series System | Abbott Medical | GKZ | Class II | |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | Unimed Medical Supplies Inc | DQA | Class II | |
| K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | |
| K242681 | NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) | Nurodata, Inc. | IYN | Class II | |
| K242447 | Falcon HST | Compumedics Limited | OLV | Class II | |
| K242240 | CaRi-Plaque | Caristo Diagnostics | LLZ | Class II | |
| K241626 | SperSort™ Sperm Sorting Chip (IPG02) | Ipreg Incorporation | MQK | Class II | |
| K241470 | CORE Shoulder System | LinkBio Corp. | QHE | Class II | |
| K234004 | Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers, Ltd. | GEX | Class II | |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | DCI International, LLC | EIA | Class I | |
| K244015 | SuperBall-RC™ | Arcuro Medical Ltd. | MBI | Class II | |
| K243761 | A.L.P.S. Small Fragment Plating System | Biomet Orthopedics, Inc. | HRS | Class II | |
| K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | OWN | Class II | |
| K243588 | Single Use CO2 Laser Fiber (HAF005001) | Quanta System Inc. | GEX | Class II | |
| K243478 | Straumann InLab Validated Workflow | Straumann USA, LLC | NHA | Class II | |
| K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | OWT | Class II | |
| K243206 | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) | Sichuan Qianli-Beoka Medical Technology Inc. | IRP | Class II | |
| K242526 | Visby Medical Respiratory Health Test | Visby Medical, Inc. | QOF | Class II | |
| K242455 | AViTA Pulse Oximeter (SP62B) | Avita Corporation | DQA | Class II | |
| K242411 | Brainomix 360 e-Lung | Brainomix Limited | JAK | Class II | |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | KCT | Class II | |
| K241666 | EVOS Pelvic and Acetabular System | Smith & Nephew, Inc. | HRS | Class II |