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 |
|---|---|---|---|---|---|
| K240155 | Cochlear Osia System | Cochlear Americas | PFO | Class II | |
| K240085 | zLOCK Lumbar Facet Fixation System | ZygoFix | MRW | Unclassified | |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics Inc. | LPH | Class II | |
| K234098 | Mobility Scooter (C4+) | Yongkang Yile Vehicle Co.,Ltd. | INI | Class II | |
| K233924 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | QJP | Class II | |
| K233850 | Difiney Anti Snoring Device | Fissiontech LLC | LRK | Class II | |
| K232627 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | DWJ | Class II | |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | MUH | Class II | |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | DeRoyal Industries, Inc. | OMP | Class II | |
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | Innova Vision Inc. | LPL | Class II | |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi ve Ticaret Ltd. Sti. | KWQ | Class II | |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | Sentinel Medical Technologies, LLC | EZL | Class II | |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co.,Ltd. | KNT | Class II | |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | JOJ | Class II | |
| K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- | Trimed Inc | HRS | Class II | |
| K233186 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | QIH | Class II | |
| K232238 | Goyo Mouthpiece S | Dimedikorea | OBR | Unclassified | |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | OMP | Class II | |
| K240748 | nextaro® v, 20/20 | SFM Medical Devices GmbH | LHI | Class II | |
| K233962 | ReBorn (1050nm) | Lightfective, Ltd. | PKT | Class II | |
| K233886 | Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 | Ambu A/S | FDT | Class II | |
| K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies | KWQ | Class II | |
| K232208 | Sectra Digital Pathology Module (Version 3.3) | Sectra AB | PSY | Class II | |
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | PSY | Class II | |
| K232133 | Co2 Laser System, Models: PureLase And VanLase | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | GEX | Class II | |
| K240884 | Glide (91000-GL-X) | Infinite Biomedical Technologies, LLC | GXY | Class II | |
| K240773 | VisAble.IO | Techsomed | QTZ | Class II | |
| K240205 | Ez Catch Auto; Ez Catch YR; Ez Catch TR | Veol Medical Technologies Pvt, Ltd. | GCJ | Class II | |
| K233411 | Folysil Silicone Catheter | MEDLINE INDUSTRIES, LP - Northfield | EZL | Class II | |
| K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | QJZ | Class II | |
| K232904 | Access Ostase | Siemens Healthcare Diagnostics Inc. | CIN | Class II | |
| K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | Medentika GmbH | NHA | Class II | |
| K232175 | XN Knee Prosthesis System | Beijing Chunlizhengda Medical Instruments Co., Ltd. | JWH | Class II | |
| K240703 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | HRS | Class II | |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific LLC | NGL | Class II | |
| K240571 | OASIS MRI System | Fujifilm Healthcare Corporation | LNH | Class II | |
| K240452 | Ceramic Femoral Head | Microport Orthopedics Inc. | LZO | Class II | |
| K240419 | UltraThineer Zirconia Slurry (5Y-B) | Boston Micro Fabrication | EIH | Class II | |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., dba Stryker Orthopaedics | JDI | Class II | |
| K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co.,Ltd | FLL | Class II | |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx | Hangzhou Aichek Medical Technology Co., Ltd. | LCX | Class II | |
| K233034 | Mobility+ Enteral Feeding System OTC | Rockfield Medical | PIF | Class II | |
| K232608 | Duo Hands-free Breast Pump | Medela AG | HGX | Class II | |
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | Shenzhen New Industries Biomedical Engineering Co.,Ltd | MRG | Class II | |
| K232489 | VenusX | Linatech, LLC | IYE | Class II | |
| K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | FBK | Class II | |
| K232164 | Access NT-proBNP | Siemens Healthcare Diagnostics Inc. | NBC | Class II | |
| K232060 | TOSAMA Reusable Applicator | TOSAMA d.o.o. | HEB | Class II | |
| K222766 | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. | FPA | Class II |