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 |
|---|---|---|---|---|---|
| K242248 | Introducer Sheath Kits | Beijing Demax Medical Technology Co., Ltd. | DYB | Class II | |
| K242126 | I.V. Administration Set | BQ Plus Medical Co., Ltd. | FPA | Class II | |
| K241979 | Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) | Beijing Konted Medical Technology Co., Ltd | IYN | Class II | |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | JDS | Class II | |
| K241803 | INSULCLOCK® v2.0 PRO | Insulcloud S.L. | QOG | Class II | |
| K241369 | LIJIA Night Guard | Lijia, LLC | MQC | Unclassified | |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. | DXT | Class II | |
| K241098 | NeuroQuant | Cortechs Labs, Inc. | QIH | Class II | |
| K240227 | LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) | LiNA Medical Inc | FAJ | Class II | |
| K234128 | Phantom Fibula Nail System | Paragon 28 | HSB | Class II | |
| K234076 | iCare ALTIUS CW | Centervue | NFJ | Class II | |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System | Tdm Co., Ltd. | HSB | Class II | |
| K242142 | Fraxel® FTX Laser System | Solta Medical, Inc. | GEX | Class II | |
| K242141 | TiLink-P SI Joint Fusion System | Surgentec LLC | OUR | Class II | |
| K242066 | iSage Rx | Amalgam Rx, Inc | NDC | Class II | |
| K241351 | Blood Pressure Monitor (TMB-2092-G) | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K241080 | Kerecis Parvus (50207) | Kerecis Limited | KGN | Unclassified | |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical, LLC | OMP | Class II | |
| K240859 | Glidewire GT-R | Terumo Corp. | DQX | Class II | |
| K240314 | Mula (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | ONF | Class II | |
| K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | FRO | Unclassified | |
| K240290 | AiMIFY (1.x) | Subtle Medical Inc | LLZ | Class II | |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. | MQV | Class II | |
| K233391 | cCeLL - In vivo | Vpix Medical, Inc. | GWG | Class II | |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation Corporation | GZF | Class II | |
| K242189 | CELERITY HP Indicator Tape (PCC077) | STERIS Corporation | JOJ | Class II | |
| K242134 | ClearCap Distal Attachment | Finemedix | OCX | Class II | |
| K241848 | MedtFine Safety Lancet | Ningbo Caremed Medical Products Co Ltd | FMK | Class II | |
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | ODP | Class II | |
| K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | JXG | Class II | |
| K241102 | Luna 4 plus | Foreo Inc | OHS | Class II | |
| K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | PROCEPT BioRobotics Corporation | PZP | Class II | |
| K240077 | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) | Medtronic, Inc. | FLL | Class II | |
| K234114 | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) | Okapi Medical, LLC dba Resivant Medical | MPN | Class II | |
| K231932 | Tds (Techwin Dental System) | Techwin Co., Ltd. | NHA | Class II | |
| K242432 | MT-Bone | Mectron S.p.A. | DZI | Class II | |
| K241870 | OnPoint Augmented Reality Spine System | Onpoint Surgical | SBF | Class II | |
| K241504 | iFuse TORQ TNT™ Implant System | SI-Bone, Inc. | OUR | Class II | |
| K241440 | HealthCCSng | Nano-X AI Ltd. | JAK | Class II | |
| K241282 | RibFix Titan™ Fixation System | Riverpoint Medical, LLC | HRS | Class II | |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA | OWN | Class II | |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way Inc. | OMP | Class II | |
| K240235 | OmniTrans Transport System | Shenzhen Dakewe Bio-Engineering Co., Ltd. | JSM | Class I | |
| K240234 | Btl-899Ms | BTL Industries, Inc | IPF | Class II | |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | Gentuity, LLC | NQQ | Class II | |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | Instrumentation Laboratory (IL) Co. | GKP | Class II | |
| K242108 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance | Ambu A/S | FGB | Class II | |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | JEY | Class II | |
| K241236 | XTRA Collection sets; XTRA Sequestration set X | Corcym Inc. | CAC | Class II |