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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical, S.L. | PBX | Class II | |
| K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | QFM | Class II | |
| K222174 | RadioLens v1.0 | Synapsica | QIH | Class II | |
| K222146 | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | PKL | Class II | |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | HIF | Class II | |
| K221938 | KLS Martin Pure Pectus System | KLS-Martin L.P. | HRS | Class II | |
| K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | MYN | Class II | |
| K220226 | X-Y Lubricating Jelly | R&R Medical Corporation Ltd. | NUC | Class II | |
| K213867 | Carestation 750/750c | GE Healthcare | BSZ | Class II | |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | FTC | Class II | |
| K223823 | Disposable Surgical Face Mask | Efofex, Inc. | FXX | Class II | |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Boston Scientific Corporation | NEY | Class II | |
| K223365 | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | EBD | Class II | |
| K223192 | XT Stain/Glaze | Shenzhen Xiangtong Co., Ltd. | EIH | Class II | |
| K222746 | Overjet Caries Assist | Overjet | MYN | Class II | |
| K200452 | Meril-Bonewax | M/s. Meril Endo Surgery Private Limited. | MTJ | Unclassified | |
| K230046 | Vinyl examination gloves | Guangdong Kingfa Sci.&tech.co.,Ltd. | LYZ | Class I | |
| K220644 | Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. | KIF | Class II | |
| K230474 | EVA5 Insufflator | Palliare | FCX | Class II | |
| K230461 | Quantra Hemostasis Analyzer | Hemosonics, LLC | QFR | Class II | |
| K230382 | 3 Series NeoLux | The Daavlin Distributing Co. | FTC | Class II | |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | KNT | Class II | |
| K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs | Mah Sing Healthcare Sdn Bhd | LZA | Class I | |
| K223803 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical USA LLC | QPP | Class II | |
| K223323 | Blood Collection Needle (with/without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | JKA | Class II | |
| K223236 | Medline Surgical Face Mask and Medline Procedural Face Mask | MEDLINE INDUSTRIES, LP - Northfield | FXX | Class II | |
| K223076 | BD Texium™ Closed Male Luer | Care Fusion | ONB | Class II | |
| K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | Becton Dickinson & Co | MDB | Class I | |
| K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | Becton Dickinson & Co | MDB | Class I | |
| K221589 | Starly pad | Shenzhen Xingyuanli Technology Co., Ltd. | GXY | Class II | |
| K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | Becton Dickinson & Co | JKA | Class II | |
| K230482 | Swedge™ Pedicle Screw Fixation System | Spinal Resources Inc | NKB | Class II | |
| K223895 | Disposable Medical Nitrile Examination Gloves | Hebei Titans Hongsen Medical Technology Co.,Ltd | LZA | Class I | |
| K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | OLO | Class II | |
| K223488 | ClosureFast™ Endovenous Radiofrequency Ablation Catheter | Medtronic, Inc. | GEI | Class II | |
| K223441 | SpaceFlex Acetabular Cup | G21, S.r.l. | KWY | Class II | |
| K223419 | Triever16 Curve | Inari Medical, Inc. | QEW | Class II | |
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) | 3M | OMP | Class II | |
| K222620 | Sterilized Latex Surgical Gloves | Suzhou Colour-way New Material Co., Ltd. | KGO | Class I | |
| K222423 | Fixone All Suture Anchor | Aju Medical Co., Ltd. | MBI | Class II | |
| K222367 | Save Gbr | Dentis Co.,Ltd | DZL | Class II | |
| K222332 | MeMed BV | MeMed Diagnostics Ltd | QPS | Class II | |
| K222151 | Sterilization Wrap | Kenpax International Limited | FRG | Class II | |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | Orthopediatrics Corp | NKB | Class II | |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | ELC | Class II | |
| K221805 | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International Ltd. | DQD | Class II | |
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit | 3M Healthcare Business Group | OMP | Class II | |
| K212394 | Implant-One Multi-Unit Abutment | Implant Logistics, Inc. | NHA | Class II | |
| K212207 | Sterile Hypodermic Syringe for Single Use | ShanDong WeiGao Group Medical Polymer Co., Ltd | FMF | Class II |