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 |
|---|---|---|---|---|---|
| K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | PSQ | Class II | |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | PSQ | Class II | |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Ever Global (Vietnam) Enterprise Corporation | LYZ | Class I | |
| K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Industria e Comercio S/a | EIA | Class I | |
| K211409 | Proximerge 2 Dental Implant System | Quadric Biomed, LLC | DZE | Class II | |
| K222721 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | LZA | Class I | |
| K222657 | MEBO Wound Dressing | Mebo Life Science, Inc. | FRO | Unclassified | |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System | Dio Medical Co., Ltd. | KWQ | Class II | |
| K222298 | Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Onetexx Sdn Bhd | LZA | Class I | |
| K222203 | DualXSLIM(R) T/PLIF | Amplify Surgical | MAX | Class II | |
| K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | Reprocessing Products Corporation (RPC) | MSY | Class II | |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | PNO | Class II | |
| K221632 | Spine CAMP™ | Medical Metrics, Inc. | QIH | Class II | |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | GE Medical Systems Information Technologies, Inc. | DPS | Class II | |
| K221072 | TRUEdraw Lancing Device, Mini Lancing Device | Trividia Health, Inc. | QRL | Class II | |
| K213978 | TELIGEN System | Medos International SARL | HRX | Class II | |
| K213123 | EVOS Wrist Spanning Plate | Smith & Nephew, Inc. | HRS | Class II | |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | CGA | Class II | |
| DEN220024 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | QRG | Class II | |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | MQB | Class II | |
| K222793 | WavelinQ™ Generator | C.R. Bard Inc | GEI | Class II | |
| K222566 | Zimmer Persona Personalized Knee System | Zimmer GmbH | MBH | Class II | |
| K222495 | Mobility Scooter, Model: W3331F | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K222209 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K222074 | Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves | Zibo Langu New Material Technology Co., Ltd. | LZA | Class I | |
| K221936 | Standalone ALIF Interbody Fusion System | Eminent Spine | OVD | Class II | |
| K221372 | YUWELL Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | |
| K221308 | Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle | Jiangxi Maidikang Medical Devices Co., Ltd. | FMF | Class II | |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | Arkray, Inc. | QRL | Class II | |
| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile | Effortless Oxygen, LLC | NFB | Class II | |
| K212746 | ATTUNE Revision Cones | Depuy Ireland UC | MBH | Class II | |
| K211785 | CASSATT™ SIJ Fixation System | CTL Medical Corporation | OUR | Class II | |
| K222791 | SafeBreak Vascular | Lineus Medical | QOI | Class II | |
| K221979 | Pulse Oximeter (Model C101A2, C101B1, C101A3) | Shenzhen Imdk Medical Technology Co., Ltd. | DQA | Class II | |
| K221574 | LUDWIG Electrosurgical Device | Aesthetics Biomedical, Inc. | GEI | Class II | |
| K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty) Ltd | BXN | Class II | |
| K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | DePuy Spine, Inc. | ODP | Class II | |
| K222797 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | MAX | Class II | |
| K222662 | Vitrea CT Cardiac Analysis | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K222537 | IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi | Shenzhen Ishine Technology Company Limited | OHT | Class II | |
| K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil | NeoCoil, LLC | MOS | Class II | |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | Applied Medical Resources Corp | GEI | Class II | |
| K221886 | Sublime Microcatheter | Surmodics, Inc. | DQY | Class II | |
| K221858 | ZSFab Lumbar Interbody System | Zsfab Inc | MAX | Class II | |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | Integra LifeSciences Production Corporation | JXG | Class II | |
| K221504 | BD Surgiphor™ Antimicrobial Irrigation System | BD | FQH | Class II | |
| K221501 | syngo.via View&GO | Siemens Healthcare GmbH | LLZ | Class II | |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA) | Southern Medical (Pty) Ltd | OVD | Class II | |
| K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | QKB | Class II | |
| K221172 | FOCUS Interbody System | Oc Medical Devices | MAX | Class II |