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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K172318 | Endoform Silver Dermal Template | AROA Biosurgery Inc. | FRO | Unclassified | |
| K172223 | SleepRight ProRx Custom Dental Guard | Splintek Inc. | OBR | Unclassified | |
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) | Xiamen Compower Medical Tech. Co., Ltd. | CBP | Class II | |
| K171743 | Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves | Smart Glove Corporation Sdn. Bhd. | LZA | Class I | |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | Siemens Healthcare Diagnostics Products Limited | DFH | Class II | |
| K171589 | AEON Endoscopic Stapler | Lexington Medical, Inc. | GDW | Class II | |
| K171270 | Digital Radiography Cxdi-410C Wireless | Canon, Inc. | MQB | Class II | |
| K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | KNS | Class II | |
| K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | MWI | Class II | |
| K170856 | CMS600P2 B-Ultrasound Diagnostic System | Contec Medical Systems Co., Ltd. | IYO | Class II | |
| K170544 | Langston dual lumen catheter | Vascular Solutions LLC | DQO | Class II | |
| K173331 | JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. | JWH | Class II | |
| K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | KaVo Dental Technologies, LLC | EHD | Class II | |
| K173314 | LessRay System | Nu Vasive, Incorporated | OWB | Class II | |
| K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) | Boston Scientific Corporation | OBJ | Class II | |
| K173187 | MobileDiagnost M50 | Philips India Limited | IZL | Class II | |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co. Ltd. | MRC | Class II | |
| K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL | Orthofix SRL | HTY | Class II | |
| K172856 | Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider | Stryker Sustainability Solutions | GEI | Class II | |
| K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | Intellijoint Surgical Inc. | OLO | Class II | |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | MBH | Class II | |
| K172550 | OEC Elite | GE Healthcare | OXO | Class II | |
| K172535 | Bipolar applicator CELON ProCurve V | Olympus Winter & Ibe GmbH | GEI | Class II | |
| K172178 | Minimally Invasive Bunion Plating System | Trilliant Surgical LLC | HRS | Class II | |
| K172130 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | MQV | Class II | |
| K171816 | Kardia Band System | AliveCor | DXH | Class II | |
| K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (dba Medical Components, Inc.) | MSD | Class II | |
| K171610 | MC3 QuickFlow Dual Lumen Catheter | Mc3 Incorporated | PZS | Class II | |
| K171543 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies, LLC | OQG | Class II | |
| K171482 | NEPHROCHECK Test System | Astute Medical, Inc. | PIG | Class II | |
| K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | EJI | Class II | |
| K170606 | Acrylic Herbst Appliance with Micro-Recorder | Gergens Orthodontic Lab | PLC | Class II | |
| K170517 | Merits Model R106/R136 Rehab Wheelchair | Merits Healthcare Industries. (Suzhou) Co., Ltd. | IOR | Class I | |
| K170022 | Klockner Vega TiBase for CEREC | Soadco, S.L. | NHA | Class II | |
| K163643 | Sirio H3 | Masmec SpA | JAK | Class II | |
| K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | MUD | Class II | |
| K173329 | jFit Surgical Planner | Jointvue, LLC | LLZ | Class II | |
| K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter | Cook Incorporated | DQO | Class II | |
| K173016 | Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color | Anhui Kindguard Medical Supplies Technology Co.,Ltd | LYZ | Class I | |
| K173003 | U50 Diagnostic Ultrasound System | Edan Instruments, Inc. | IYN | Class II | |
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | OCW | Class II | |
| K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | Zhonghong Pulin Medical Products Co.,Ltd. | LZA | Class I | |
| K171815 | Registrado Scan | Voco GmbH | EBF | Class II | |
| K171736 | Geri Embryo Incubator and Geri Dish | GENEA BIOMEDX Pty Ltd. | MQG | Class II | |
| K170362 | Vortek Hydro-Coated Double Loop Ureteral Stents | MEDLINE INDUSTRIES, LP - Northfield | FAD | Class II | |
| K170206 | Arthrex FiberTape Cerclage | Arthrex GmbH | JDQ | Class II | |
| DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay | Memorial Sloan-Kettering Cancer Center | PZM | Class II | |
| DEN170018 | NSS-2 System | Innovative Health Solutions (Ihs), Inc. | PZR | Class II |