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 |
|---|---|---|---|---|---|
| K240720 | TiLink-P SI Joint Fusion System | Surgentec LLC | OUR | Class II | |
| K240719 | OC JuggerKnot Soft Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K233757 | TitanPico Laser Workstation (PICO-450) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | |
| K233698 | True Enhance DL | GE Healthcare Japan Corporation | JAK | Class II | |
| K232999 | Lyric4 Hearing Aid | Sonova AG | ESD | Class I | |
| K221847 | Ni2 Implant System | Newton Implant Systems | DZE | Class II | |
| K202531 | Azer Scientific Universal Transport Medium | Azer Scientific, Inc. | JSM | Class I | |
| K240760 | CELERITY HP Indicator Tape | STERIS Corporation | JOJ | Class II | |
| K240744 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech(hangzhou)co.,Ltd | NGL | Class II | |
| K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K234057 | Nirvana | El.En S.p.A. | GEX | Class II | |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System | Surnic Corporation | FYD | Class II | |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corp. | OBO | Class II | |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | Zavation Medical Products, LLC | MAX | Class II | |
| K233313 | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | DQD | Class II | |
| K232641 | Neorad Pacs (Neorad Pacs) | Everrtech Software Pvt, Ltd. | LLZ | Class II | |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | CAF | Class II | |
| K232409 | Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co.,Ltd. | NGX | Class II | |
| K233999 | GalaFLEX LITE Scaffold | Tepha, Inc. | OOD | Class II | |
| K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. | GCJ | Class II | |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | JAQ | Class II | |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee BioMedical, Inc. | KRH | Class II | |
| K232147 | CAAS Workstation | PIE Medical Imaging B.V. | QHA | Class II | |
| DEN230023 | Rho | 16 Bit Inc | SAO | Class II | |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | KWQ | Class II | |
| K240291 | Efai Cardiosuite Cta Acute Aortic Syndrome Assessment System | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | |
| K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Yue Kang Anhui Medical Products Co.,Ltd | LZA | Class I | |
| K231728 | BiWaze Clear System | Abmrc LLC | NHJ | Class II | |
| K212878 | Sample preservation solution | Zhejiang Gene Science Co., Ltd | QBD | Class II | |
| K240737 | G Surgical Marksman MIS System | G Surgical Co., Ltd. | NKB | Class II | |
| K240647 | Virage® Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | OLO | Class II | |
| K240360 | Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. | OHS | Class II | |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories Inc. | LCX | Class II | |
| K234105 | Catalyst F1x Shoulder System | CATALYST ORTHOSCIENCE Inc | PHX | Class II | |
| K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corp | NXC | Class II | |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | Macrolux Medical Technology Co., Ltd. | EOQ | Class II | |
| K233666 | CorVista System with PH Add-On | Analytics for Life Inc. | SAT | Class II | |
| K233249 | Appraise-Hri | The Surgeon General, Department of the Army (TSG-DA) | SAR | Class II | |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Co., Ltd | FLL | Class II | |
| K232919 | Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 | Ambu A/S | FDS | Class II | |
| K232823 | Mcg-S (Am1000) | Amcg Co., Ltd. | DPS | Class II | |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) | Icotec AG | MAX | Class II | |
| K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | HRS | Class II | |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene LLC | QKM | Class II | |
| K223914 | ACTIV™ Cap | Cleansite Medical, Inc. | QBP | Class II | |
| DEN230032 | Symani Surgical System | Mmi North America, Inc. | SAQ | Class II | |
| DEN220015 | Orthobond Mariner Pedicle Screw System | Orthobond Coporation | QZY | Class II | |
| DEN210058 | ELEOSx™ Limb Salvage System | Onkos Surgical, Inc. | QZZ | Class II | |
| K240652 | Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II |