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 |
|---|---|---|---|---|---|
| K173143 | Phasix ST Mesh | C.R. Bard Inc | OWT | Class II | |
| K162525 | Oniko nail brace | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti | MQZ | Unclassified | |
| K180277 | Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | Smith & Nephew, Inc. | OLO | Class II | |
| K180252 | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank | Crown Porcelain Dental Technology Co., Ltd. | EIH | Class II | |
| K180225 | GSI Viewer with GSI Fat Option | GE Medical Systems SCS | JAK | Class II | |
| K180222 | Reaxon Plus | Medovent GmbH | JXI | Class II | |
| K180206 | neuromate Gen III | Renishaw Mayfield SARL | HAW | Class II | |
| K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | Medtronic, Inc. | FTL | Class II | |
| K173865 | trophon2 | Nanosonics Limited | OUJ | Class II | |
| K172768 | Zoom | Zetta Medical Technologies, LLC | LLZ | Class II | |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | JDX | Class II | |
| K162314 | IMACTIS CT-Navigation system | Imactis, SAS | JAK | Class II | |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | Stryker Sustainability Solutions | NUJ | Class II | |
| K180090 | Cure™ Lumbar Plate System | Meditech Spine, LLC | KWQ | Class II | |
| K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | Class II | |
| K173715 | AlertWatch:OB | Alertwatch, Inc. | HGM | Class II | |
| K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader | 3M Company | FRC | Class II | |
| K172699 | Agile Nail | Orthofix SRL | HSB | Class II | |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2 | Abbott Medical | DQK | Class II | |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | Abbott Medical | MTD | Class II | |
| K172329 | Patient Status Engine | Isansys Lifecare, Ltd. | DRG | Class II | |
| K171917 | Frova Intubating Introducer | Cook Incorporated | BTR | Class II | |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. | LKM | Class II | |
| K180782 | Aria | GE Healthcare | KGI | Class II | |
| K180765 | Televere Podiatry X-Ray System HF | Televere Systems | KPR | Class II | |
| K180753 | SafetyFix EasyOut System | Safetyfix Medical Technologies, Inc. | HWC | Class II | |
| K180750 | World Knee System | Signature Orthopaedics Pty Limited | JWH | Class II | |
| K180618 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Ltd | OMP | Class II | |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | NUJ | Class II | |
| K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | Visco Vision Inc. | LPL | Class II | |
| K180304 | Geri Embryo Incubator and Geri Dish | GENEA BIOMEDX Pty Ltd. | MQG | Class II | |
| K180219 | JO H2O Flavored Personal Lubricants | United Consortium | NUC | Class II | |
| K180161 | Viz CTP | Viz. Ai, Inc. | LLZ | Class II | |
| K180140 | ProFlex Laser Fibers | Innovaquartz LLC | GEX | Class II | |
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | Toshibamedical Systems Corporation | IYN | Class II | |
| K173902 | Neodent Implant System – GM Line | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex GmbH | PHX | Class II | |
| K173855 | Sharpsite AC Rigid Endsocope | Medtronic Xomed, Inc. | EOB | Class II | |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | PT. Medisafe Technologies | KGO | Class I | |
| K172511 | Hickman TriFusion Catheter | C.R. Bard Inc | LJS | Class II | |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Euroimmun US Inc. | KTL | Class II | |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Euroimmun US Inc. | KTL | Class II | |
| K171443 | Etherea MX | Vydence Medical Industria e Comercio Ltda | GEX | Class II | |
| DEN170081 | MALDI Biotyper CA System | Bruker Daltonik GmbH | QBN | Class II | |
| DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | Lin-Zhi International Inc | QBK | Class II | |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | |
| K180731 | Ultramatrix EUS Balloon | United States Endoscopy Group, Inc. (Us Endoscopy) | ODG | Class II | |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics GmbH | GJS | Class II | |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics GmbH | GJS | Class II | |
| K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | Lpi, Inc. | LEJ | Class II |