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 |
|---|---|---|---|---|---|
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | |
| K254021 | Accuro XV | Rivanna Medical, Inc | IYO | Class II | |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | QJP | Class II | |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | Anhui Happiness Workshop Instruments Co., Ltd. | FGB | Class II | |
| K252251 | Easymade-Ti | CG Bio Co., Ltd. | GXN | Class II | |
| K252228 | Seaman Pro/Seaman | Checkcells, Inc. | POV | Class II | |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Boston Scientific Corporation | OBJ | Class II | |
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | FRC | Class II | |
| K260477 | CATAMARAN™ SI Joint Fusion System | Tenon Medical, Inc. | OUR | Class II | |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | Macrolux Medical Technology Co., Ltd. | EOQ | Class II | |
| K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | GCJ | Class II | |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix | GCJ | Class II | |
| K260033 | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K253534 | Pivot Insulin Delivery System | Modular Medical | LZG | Class II | |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | CMT Health Pte. Ltd. | PNR | Class II | |
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | |
| K252224 | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | LQY | Unclassified | |
| K251889 | myAir | ResMed Corp | MNS | Class II | |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | MED | Class II | |
| K260942 | AuST Steerable Sheath | Centerpoint Systems LLC | DYB | Class II | |
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology Inc. | LYZ | Class I | |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang Shuyou Surgical Instrument Co., Ltd | GEI | Class II | |
| K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics GmbH | SEI | Class II | |
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics GmbH | LOL | Class II | |
| K260046 | Elecsys Anti-HBc II | Roche Diagnostics GmbH | SEI | Class II | |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | FRO | Unclassified | |
| K253952 | Power Wheelchair (OS-R-M01S) | Beijing Orionstar Technology Co., Ltd. | ITI | Class II | |
| K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K253905 | PrimeSight UltraView System | Cogentix Medical, Inc. | FAJ | Class II | |
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana Inc. | SHP | Class II | |
| K252979 | Voyager DSLT (430840610) | Belkin Vision Ltd. | HQF | Class II | |
| K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | DWJ | Class II | |
| K252116 | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd | LOX | Class II | |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. | FED | Class II | |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | DYB | Class II | |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | GEI | Class II | |
| K254091 | Glossy Coat (15Ml) | Yamahachi Dental Mfg. Co. | EBD | Class II | |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | KWS | Class II | |
| K253862 | APERTO Lucent MRI System | FUJIFILM Corporation | LNH | Class II | |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote S.p.A. | IYN | Class II | |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd | EBF | Class II | |
| K253025 | Ricoh 3D for Healthcare Bolus | Ricoh 3D for Healthcare, LLC | IXI | Class II | |
| K252809 | in2 Smart (in2S) | Virility Medical Ltd. | QRC | Class II | |
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | PLC | Class II | |
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MNT | Class II | |
| K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | HGX | Class II | |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | |
| K260724 | Magentiq-Colo (Me-Apds) | Magentiq Eye Ltd | QNP | Class II |