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 |
|---|---|---|---|---|---|
| K232521 | ExactechGPS® Total Ankle Application | Blue Ortho | OLO | Class II | |
| K232392 | CT Lung Ventilation Analysis Software (CT:V) | 4DMEDICAL Limited | JAK | Class II | |
| K232139 | Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens | Innova Vision Inc. | LPL | Class II | |
| K231738 | NEUWAVE™ Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | |
| K231694 | MASADA Modular Spinal Fixation System | Astura Medical | NKB | Class II | |
| K231652 | D100 Kids; D101 Kids | Corcym Inc. | DTZ | Class II | |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | PHX | Class II | |
| K230451 | Aptima® Chlamydia trachomatis Assay | Hologic, Inc. | MKZ | Class I | |
| K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K232841 | Axial3D Insight | Axial Medical Printing Limited | QIH | Class II | |
| K231852 | BinkieRT | Papricalab | IYE | Class II | |
| K231818 | METIC™- Airway Balloon Catheter | M/S Meril Life Sciences Pvt., Ltd. | KTI | Class II | |
| K231012 | CoolSeal Trinity | Bolder Surgical, LLC | GEI | Class II | |
| K230463 | NSite Scoliosis Assessment App | Nsite, Inc. | LDK | Unclassified | |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | EBZ | Class II | |
| DEN200070 | Simple 2 Test | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | QYA | Class II | |
| K233468 | Iconix Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | Prismatik Dentalcraft, Inc. | LRK | Class II | |
| K232845 | IPL Cooling Hair Removal Device | Shenzhen Siken 3D Technology Development Co., Ltd. | OHT | Class II | |
| K232656 | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc | OLP | Class II | |
| K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | Kossan International Sdn Bhd | LZA | Class I | |
| K232092 | Great Basin Toxigenic C. difficile Direct Test (CDF2) | Vela Operations USA | OZN | Class II | |
| K232050 | saremco print BRIDGETEC | Saremco Dental AG | EBF | Class II | |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | ITX | Class II | |
| K231554 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | KRD | Class II | |
| K231521 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | EOQ | Class II | |
| K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | GKZ | Class II | |
| K230856 | BrainSpec Core™ Software | Brainspec, Inc | LLZ | Class II | |
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | |
| K232257 | Clarius Bladder AI | Clarius Mobile Health Corp | QIH | Class II | |
| K232241 | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) | Betters(Suzhou) Medical Co., Ltd | NEY | Class II | |
| K232240 | Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd | NEY | Class II | |
| K232083 | BriefCase-Quantification | Aidoc Medical Ltd. | QIH | Class II | |
| K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | KGN | Unclassified | |
| K231118 | Cystoscope System | Shenzhen Hugemed Medical Technical Development Co., Ltd | FAJ | Class II | |
| K230849 | Ellavi Ubt | Sinapi Biomedical (Pty) Ltd | OQY | Class II | |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | MBF | Class II | |
| K231564 | Skin and Wound Cleanser | Winner Medical Co., Ltd. | FRO | Unclassified | |
| K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBF | Class II | |
| K233408 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise N.V. | QHE | Class II | |
| K233366 | SYMPHONY OCT System | Medos International SARL | NKG | Class II | |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-NX Co., Ltd. | EKX | Class I | |
| K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co.,Ltd | FBK | Class II | |
| K231920 | Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions | GXN | Class II | |
| K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | Medacta International SA | PHX | Class II | |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | FUJIFILM Biosciences Inc. | NDS | Class II | |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics Inc | DJG | Class II |