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 |
|---|---|---|---|---|---|
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Industria e Comercio Ltda | ELW | Class II | |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics Inc. | MBH | Class II | |
| K252442 | Kii Structural Balloon Access System | Applied Medical Resources Corp | GCJ | Class II | |
| K252427 | Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd | GEX | Class II | |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corp | GEI | Class II | |
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development LLC | OMB | Class II | |
| K252088 | Firebird SI Navigation System | Orthofix SRL | OLO | Class II | |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | |
| K252060 | Green | Phasor Health, LLC | HBE | Class II | |
| K251547 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | GXY | Class II | |
| K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | FDS | Class II | |
| K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. | FGB | Class II | |
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton Dickinson & Co | PCI | Class II | |
| K250338 | MSS - Humeral reverse liners extension | Medacta International SA | PHX | Class II | |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | FRG | Class II | |
| DEN240074 | Pulsenmore ES | Pulsenmore Ltd | SGJ | Class II | |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | Boston Scientific Corporation | KRD | Class II | |
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co Ltd | ESW | Class II | |
| K252752 | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | QAI | Class II | |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co.,Ltd | JMT | Class I | |
| K252529 | Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) | Boston Scientific Corporation | GEX | Class II | |
| K252430 | Freeprint® denture flex | Detax GmbH | EBI | Class II | |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OAP | Class II | |
| K252387 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | DiaSorin Molecular LLC | QOF | Class II | |
| K252046 | Zoom System (Zoom 4S Catheter) | Imperative Care Inc. | NRY | Class II | |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | DZE | Class II | |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | TORNIER Inc. | KWT | Class II | |
| K251531 | Air Compression Boots 1018195,1018196 | Merchsource LLC | IRP | Class II | |
| K250632 | Arctx Cool Catheter Set | Arctx Medical | PLA | Class II | |
| K250337 | AiORTA - Plan | Vitaa Medical Solutions Inc | QIH | Class II | |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (BD) | FPA | Class II | |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | ESW | Class II | |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech LLC | LRK | Class II | |
| K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | PHX | Class II | |
| K253323 | Protrieve Sheath | Inari Medical, Inc. | QEW | Class II | |
| K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics Inc. | JWH | Class II | |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K253232 | Seguin Annuloplasty Ring | Abbott Medical | KRH | Class II | |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) | SU-KO Technologies LLC | QAI | Class II | |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | KWS | Class II | |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | MMI | Class II | |
| K252390 | Telescope Guide Extension Catheter | Medtronic Ireland | DQY | Class II | |
| K252314 | Arthrex SutureTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K251985 | Logiq E10 | GE Healthcare | IYN | Class II | |
| K251963 | LOGIQ E10s | GE Healthcare | IYN | Class II | |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | HQF | Class II | |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc. (Stryker) | HTN | Class II |