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 |
|---|---|---|---|---|---|
| K172234 | Oxygen Concentrator | Sysmed (China) Co., Ltd | CAW | Class II | |
| K172068 | Kenz Cardico1211 | Suzuken Co., Ltd. | DPS | Class II | |
| K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | GXY | Class II | |
| K181177 | Interventional Workspot | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | Datascope Corp. | DSP | Class II | |
| K181098 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K180606 | SOMAVAC Device | Somavac Medical Solutions, Inc. | BTA | Class II | |
| K180582 | Sternal Cable System | A & E Medical Corporation | JDQ | Class II | |
| K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | PHM | Class II | |
| K180464 | AEVUMED PHANTOM Suture Anchors | Aevumed, Inc. | MBI | Class II | |
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | NAY | Class II | |
| K173415 | EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. | NAY | Class II | |
| K172690 | ToFscan | Idmed | KOI | Class II | |
| K171828 | ETCO2 Sensor | Orantech Inc. | CCK | Class II | |
| K170703 | Single Use Arthroscopic Electrode (with Pencil) | Modern Medical Equipment Manufacturing Ltd. | HRX | Class II | |
| K181188 | EVEREST Spinal System | K2M, Inc | NKB | Class II | |
| K180361 | MICRORAPTOR REGENESORB Suture Anchor | Smith & Nephew, Inc. | MAI | Class II | |
| K180293 | Retia 2 | Centervue | MYC | Class II | |
| K180167 | Playtex Stella Tampons | Playtex Manufacturing Inc. | HEB | Class II | |
| K173951 | Legend Acetabular Liners | Ortho Development Corp. | LPH | Class II | |
| K173483 | Pure Flow External Counter-Pulsation Device | Xtreem Pulse | DRN | Class II | |
| K173269 | KATOR Suture Anchor | Kator, LLC | MBI | Class II | |
| K173246 | Aneroid Sphygmomanometer | Wenzhou Bokang Instruments Co., Ltd. | DXQ | Class II | |
| K172825 | Mn-111 | W&H Sterilization S.r.l. | FLE | Class II | |
| K171019 | ScioCardio ECG Transmitter | Synergen Technology Labs, LLC | DRG | Class II | |
| K181132 | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic, Inc. | KRH | Class II | |
| K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | Supersonic Imagine | IYN | Class II | |
| K180553 | VERIFY Spore Test Strip for S40 Sterilant | STERIS Corporation | OVY | Class II | |
| K180174 | Belun Ring | Belun Technology Company Limited | DQA | Class II | |
| K173157 | Dr's Light2 | Good Doctors Co., Ltd. | EBZ | Class II | |
| K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd | NDN | Class II | |
| K181150 | ProtekDuo Mini Veno-Venous Cannula Set | Cardiacassist, Inc. | DWF | Class II | |
| K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics Inc. | NDY | Class II | |
| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100 | FUJIFILM Corporation | FCX | Class II | |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | Iridex Corporation | HQF | Class II | |
| K180356 | inui In-Home Urine Analysis Test System | Scanadu, Inc. | JIL | Class II | |
| K180163 | TransEnterix Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K180111 | ClearGuard HD Antimicrobial Barrier Cap | Pursuit Vascular, Inc. | PEH | Class II | |
| K173914 | VORTRAN Cuff Inflator (VCI) | Vortran Medical Technology 1, Inc | BSK | Class II | |
| K173834 | Quantum Pump Console | Spectrum Medical Inc | DTQ | Class II | |
| K173005 | SURECELL Gelling Fiber Wound Dressing | Jiangsu Newvalue Medical Producst Co.,Ltd | KGN | Unclassified | |
| K172889 | Infrared Thermometer | Shenzhen Pacom Medical Instruments Co., Ltd. | FLL | Class II | |
| K172717 | Automatic Tissue Processing Unit | Bsl Co. | MUU | Class II | |
| K172242 | DripAssist Plus | Shift Labs | FLN | Class II | |
| K172147 | Star 65 | Skanray Technologies Pvt, Ltd. | MWI | Class II | |
| K181136 | Cs 9600 | Trophy | OAS | Class II | |
| K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | |
| K181080 | McKesson Cardiology | Change Healthcare Israel Ltd. | LLZ | Class II | |
| K181077 | ActiGraph CentrePoint Insight Watch | ActiGraph L.L.C. | LEL | Class II | |
| K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | PixxGen Corporation | MQB | Class II |