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 |
|---|---|---|---|---|---|
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co. Ltd. | EGS | Class I | |
| K162510 | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue | UG Global Resources Sdn Bhd | LZA | Class I | |
| K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | HQD | Class II | |
| K171115 | 3D Endo Software | Dentsply Sirona Inc | LLZ | Class II | |
| K170613 | Genius Total Knee System | Signature Orthopaedics Pty Limited | JWH | Class II | |
| K170607 | !M1 | Solutions for Tomorrow AB | IZL | Class II | |
| K170407 | BD ChloraShield IV Dressing with CHG Antimicrobial | Avery Dennison Belgie Bvba | FRO | Unclassified | |
| K162957 | U2 Femoral Head | United Orthopedic Corp. | LPH | Class II | |
| K171907 | Vitality® Spinal Fixation System | Highridge Medical, LLC | NKB | Class II | |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System | Cerenovus, Inc. | HCG | Class II | |
| K171539 | Contact Lens Case | E-Link Plastic & Metal Industrial Co.,Ltd | LRX | Class II | |
| K171522 | truFreeze Rapid AV Spray Kit | CSA Medical | GEH | Class II | |
| K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | NQW | Class II | |
| K171242 | Alma LipoFlow System | Alma Lasers Ltd. | MUU | Class II | |
| K171128 | SIGNA Premier | GE Healthcare | LNH | Class II | |
| K171029 | eCareCoordinator | Visicu, Inc. | DRG | Class II | |
| K170798 | Dictum Health | Dictum Health, Inc. | MWI | Class II | |
| K170757 | Aegis Transit System | Boston-Biomedical Associates | EWY | Class II | |
| K170710 | True Spinal Fixation System | Innovative Surgical Designs, Inc. | NKB | Class II | |
| K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | Brightway Holdings Sdn. Bhd. | LZA | Class I | |
| K170637 | sensiFirm | El Global Trade Ltd. | PBX | Class II | |
| K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | HRS | Class II | |
| K170090 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | LNH | Class II | |
| K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | MQF | Class II | |
| K163194 | Neodent Implant System - GM Line | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K163150 | ViMove2 | Dorsavi Ltd | IKN | Class II | |
| K162853 | Bonafix TWO - Dental Implant System | Bonafix Surgical and Dental Implants, LLC | DZE | Class II | |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | Vascutek, Ltd. | DSY | Class II | |
| K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload | Golden Stapler Surgical Co., Ltd. | GDW | Class II | |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co.,Ltd | JLW | Class II | |
| K162153 | Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System | Ascension Orthopedics, Inc. | HWC | Class II | |
| K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho-Clinical Diagnostics, Inc. | DCK | Class II | |
| K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K171749 | Velofix(tm) Interbody Fusion System | CG MedTech Co., Ltd. | ODP | Class II | |
| K171656 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | MAX | Class II | |
| K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | Extremity Medical, LLC | HWC | Class II | |
| K170986 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. | EIH | Class II | |
| K170808 | Unity Total Knee System | Corin USA | JWH | Class II | |
| K170676 | HD Lumbar Interbody System | Hd Lifesciences, LLC | MAX | Class II | |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | HIH | Class II | |
| K170550 | Coveris Cervical Cage System | Camber Spine Technologies | ODP | Class II | |
| K162878 | Kitazato ET Catheters | Kitazato Corporation | MQF | Class II | |
| K162815 | SterilContainer S System | Aesculap Inc | KCT | Class II | |
| K171800 | OEC Elite MiniView | GE Hualun Medical Systems Co., Ltd. | OXO | Class II | |
| K171766 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | IYO | Class II | |
| K171733 | TrueBeam, TrueBeam STx, Edge | Varian Medical Systems, Inc. | IYE | Class II | |
| K170999 | P50 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx | Invacare GmbH | ITI | Class II | |
| K170435 | NerveGuard NRFit, NerveGuard LUER | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | ODP | Class II |