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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K201976 | SnapshotNIR | Kent Imaging Inc | MUD | Class II | |
| K200886 | StimSite | Allotrope Medical, Inc. | ETN | Class II | |
| K200428 | Multi-Drive Interference Screw System | Nvision Biomedical Technologies, Inc | MBI | Class II | |
| K200098 | VagiVital Aktivgel | Peptonic Medical AB | NUC | Class II | |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | Zimmer GmbH | MBI | Class II | |
| K183044 | JTK Dental Implant System | Jiangyin Jintech Biotech Co., Ltd. | DZE | Class II | |
| K203128 | Evis Eus Endoscopic Ultrasound Center Olympus EU-Me2/evis Eus Endoscopic Ultrasound Center Olympus EU-Me2 Premier Plus | Olympus Medical Systems Corp. | IYN | Class II | |
| K203110 | iFuse Implant System - iFuse Navigation | SI-Bone, Inc. | OLO | Class II | |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits | Boston Scientific Neuromodulation Corporation | GZB | Class II | |
| K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | GZJ | Class II | |
| K201269 | Accula Strep A Test | Mesa Biotech, Inc. | PGX | Class II | |
| K200005 | Concinnity Aligners | Drake Precision Dental Laboratory, Inc. | NXC | Class II | |
| K193432 | Vantage PSI System | 3D Systems, Inc. | OYK | Class II | |
| K193190 | BD PureHub Disinfecting Cap | Becton Dickinson & Co | QBP | Class II | |
| K203076 | Mecta-C Stand Alone Extension | Medacta International SA | OVE | Class II | |
| K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) | STERIS Corporation | FLE | Class II | |
| K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. dba Sota Imaging | MUH | Class II | |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System | Medartis AG | HWC | Class II | |
| K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K202583 | BioShield biopsy valve EUS - Linear | STERIS Corporation | ODD | Class II | |
| K202427 | Aqueduct 100 Plus Cervical Dilation Balloon Catheter | Gtimd, LLC | PON | Class II | |
| K201669 | SimpleSENSE | Nanowear, Inc. | DXH | Class II | |
| K201091 | V-Print splint | Voco GmbH | MQC | Unclassified | |
| K200811 | cobas u 701 microscopy analyzer | Roche Diagnostics GmbH | LKM | Class II | |
| K200750 | Neuro.Al Algorithm | Terarecon, Inc. | LLZ | Class II | |
| K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | HIS | Class II | |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | LBH | Class II | |
| K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | QKB | Class II | |
| K192621 | Medical RF | Triworks Group S.r.l. | GEI | Class II | |
| DEN200033 | NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable | Nightware | QMZ | Class II | |
| K203154 | KASILOF Cervical Plate System | Kahtnu Surgical, Inc. | KWQ | Class II | |
| K203025 | LOBO Vascular Occlusion System (model LOBO-5) | Okami Medical Inc. | KRD | Class II | |
| K202476 | Salvo® Spine System | Spine Wave Inc | NKB | Class II | |
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies ULC. (Now A Part of Stryker) | OWN | Class II | |
| K201902 | MammaPrint | Agendia Inc | NYI | Class II | |
| K201877 | OtoSet- Ear Cleaning System | Safkan, Inc. | KYZ | Class I | |
| K201827 | GR-17 Resin System | PRO3DURE Medical GmbH | EBG | Class II | |
| K201741 | Gabriel 3 Way EnFit Valve | Syncro Medical Innovations, Inc. | PIF | Class II | |
| K200017 | Eclipse DermaFlex Cannula | Eclipse Medcorp, LLC | FMI | Class II | |
| K202624 | Z-Span Plate System | Zavation Medical Products, LLC | KWQ | Class II | |
| K202581 | Arthrex TightRope II | Arthrex GmbH | MBI | Class II | |
| K202422 | Arietta 65 | FUJIFILM Healthcare Americas Corporation | IYN | Class II | |
| K201941 | Monitor B125, Monitor B105 | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | Rebound Therapeutics, Corporation | GWG | Class II | |
| K200350 | MyHip Planner & Verifier | Medacta International SA | LLZ | Class II | |
| K193499 | DigiGuide System | Protomed Corp. | DZJ | Class II | |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | Sweden & Martina Inc | KCT | Class II | |
| K202198 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | |
| K201683 | PMMA Block | Huge Dental Material Co., Ltd. | EBG | Class II |