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 |
|---|---|---|---|---|---|
| K210979 | Prelivia | Rehabtronics, Inc. | IPF | Class II | |
| K210874 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | NKB | Class II | |
| K210815 | Disposable Face Mask | Biobase Scientific (Shandong) Co., Ltd. | FXX | Class II | |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | PENTAX of America, Inc. | FDS | Class II | |
| K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K210369 | Powder Free Nitrile Examination Glove | Pastel Glove Sdn Bhd | LZA | Class I | |
| K203566 | Tablet Application | Smith & Nephew, Inc. | ODA | Class II | |
| K203481 | CryoVIVE | Recensmedical Inc. | GEH | Class II | |
| K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | JWH | Class II | |
| K202697 | United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask | United Sewing Automation, Inc. | FXX | Class II | |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | Prevest Denpro Limited | EMA | Class II | |
| K210974 | High Performance Antimicrobial Gelling Fiber with Silver | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K210809 | iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) | ConforMIS, Inc. | JWH | Class II | |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | MED | Class II | |
| K210689 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K210557 | Symbia VA10A Family | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K210439 | NuVasive MOD-EX XLIF Interbody System | Nu Vasive, Incorporated | MAX | Class II | |
| K210435 | Automatic Arm Electronic Blood Pressure Monitor | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | DXN | Class II | |
| K210153 | NextAR RSA Platform | Medacta International SA | SBF | Class II | |
| K210967 | Air Pressure Therapy System: VU-IPC06 | Xiamen Weiyou Intelligent Technology Co.,Ltd | IRP | Class II | |
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | Ibramed Equipamentos Medicos | IPF | Class II | |
| K203228 | DART-FIRE EDGE Cannulated Screw System | Wright Medical | HWC | Class II | |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co Ltd | FGE | Class II | |
| K202860 | Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) | Valley Contax, Inc | HQD | Class II | |
| K202272 | HD Mediastinoscope | Karl Storz Endoscopy-America, Inc. | EWY | Class II | |
| K210168 | Diode Laser Therapy Systems | Beijing Kes Biology Technology Co., Ltd. | GEX | Class II | |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd | EKX | Class I | |
| K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine LLC | OVE | Class II | |
| K201504 | Single-use medical poly (vinyl chloride) examination glove | Anhui Bytech Medical Supplies Co., Ltd. | LYZ | Class I | |
| K193649 | Yumizen C1200 Creatinine PAP | Horiba Abx SAS | JFY | Class II | |
| K190737 | Solax Electric Scooter (Models: S204311M, S204161, S204143) | Dongguan Prestige Sporting Goods Co., Ltd. | INI | Class II | |
| K210755 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) | Meditech Gloves Sdn Bhd | LZA | Class I | |
| K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | Onetexx Sdn Bhd | LZA | Class I | |
| K210218 | SURGICAL MASK, Model Name:C015 | Qingdao Hainuo Biological Engineering Co., Ltd. | FXX | Class II | |
| K203847 | Reprocessed Tri Pulse Compression Garment | Renu Medical, Inc. | JOW | Class II | |
| K203832 | FuseForce™ Flex Dynamic Compression System | Wright Medical | JDR | Class II | |
| K203572 | Karl Storz Radel Sterilization Trays | Karl Storz Endoscopy-America, Inc. | KCT | Class II | |
| K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) | Central Medicare Sdn Bhd | LZA | Class I | |
| K202145 | Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | QLG | Class II | |
| K211034 | Corvus Radiation Therapy Planning System | Best Nomos | MUJ | Class II | |
| K210728 | CONDUIT Instruments | Medos International SARL | MAX | Class II | |
| K210705 | Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 | Defender Safety, Inc. | FXX | Class II | |
| K210529 | Dr. Yglo Wart Remover | Theotclab Healthcare B.V. | GEH | Class II | |
| K210353 | AutoCap RX | Boston Scientific Corporation | ODC | Class II | |
| K210191 | Identity Imprint Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K210066 | ImagePilot | Konica Minolta, Inc. | LLZ | Class II | |
| K203640 | CoolSeal Reveal | Bolder Surgical, LLC | GEI | Class II | |
| K203183 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) | Bolder Surgical, LLC | GEI | Class II | |
| K202971 | DRPx Locking Distal Radius Plate System | The Orthopaedic Implant Company | HRS | Class II | |
| K202598 | 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 | 3A Medical Products Co., Ltd. | FXX | Class II |