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 |
|---|---|---|---|---|---|
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty Ltd | IZQ | Class II | |
| K241484 | Atlas™ Humeral Nail System | Orthopedic Designs North America, Inc. (Odi-Na) | HSB | Class II | |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | Terarecon, Inc. | QIH | Class II | |
| K240624 | InfuLife | First Medical Source LLC | MEB | Class II | |
| K231287 | Potenza | Jeisys Medical Inc. | GEI | Class II | |
| K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | DYB | Class II | |
| K242709 | Jlk-Pwi | JLK, Inc. | LLZ | Class II | |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | Changsha Anxiang Medical Technology Co., Ltd | NUH | Class II | |
| K242195 | Gemini Cervical Fusion Cage System | Zhejiang Decans Medical Devices Co.,Ltd. | ODP | Class II | |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | NBW | Class II | |
| K240512 | Tixel i (TXLI0001) | Novoxel Inc. | ORZ | Class II | |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | FRG | Class II | |
| DEN230083 | Valeda Light Delivery System | Lumithera, Inc. | SDE | Class II | |
| K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc | JWJ | Class II | |
| K243217 | Legend X Desktop System | Pollogen Ltd | GEI | Class II | |
| K243091 | Over-tube (TR-1108A) | FUJIFILM Corporation | FED | Class II | |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. | KLE | Class II | |
| K242665 | DePuy ATTUNE™ Total Knee System | Depuy Orthopedics, Inc. | OIY | Class II | |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd | OAP | Class II | |
| K242591 | XERO-alpha | DRTECH Corporation | EHD | Class II | |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28 | KTT | Class II | |
| K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers Inc. | HQD | Class II | |
| K242320 | BD Vacutainer® One Use Holder | Becton Dickinson & Co | JKA | Class II | |
| K242311 | EXPERT - Flexible Joint Fixation System | GM dos Reis Industria e Comercio Ltda | HTN | Class II | |
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) | Quanta Dialysis Technologies Ltd | ONW | Class II | |
| K242076 | VersaCross™ RF Wire | Baylis Medical Co., Inc. | DXF | Class II | |
| K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | HSN | Class II | |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | DQK | Class II | |
| K241646 | Ortiv (Ortiv-Bl, Ortiv-Wh) | Mvitro Co., Ltd. | GEX | Class II | |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | |
| K240881 | Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) | Covidien (Part of Medtronic) | GAG | Class II | |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology Inc | KOB | Class II | |
| K240388 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | HRS | Class II | |
| K240366 | EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | |
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | FRO | Unclassified | |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. | DXQ | Class II | |
| K242399 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | HRS | Class II | |
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports | Bard Access Systems, Inc. | LJT | Class II | |
| K241223 | eRAD PACS | Erad, Inc. | LLZ | Class II | |
| K240653 | SmartCardia 7L Platform (MCT) | Smartcardia SA | QYX | Class II | |
| K240455 | BD Vacutainer® Citrate Blood Collection Tubes | Becton Dickinson & Co | GIM | Class II | |
| K240383 | Highness Implant System | Highness Co.,Ltd. | DZE | Class II | |
| K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | CAD | Class II | |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | HSX | Class II | |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | FMK | Class II | |
| K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd | SBF | Class II | |
| K241902 | Edison System | Histosonics, Inc | QGM | Class II | |
| K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis, Inc | QHH | Class II | |
| K241108 | RemedyLogic AI MRI Lumbar Spine Reader | Remedy Logic, Inc. | QIH | Class II |