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 |
|---|---|---|---|---|---|
| K223091 | CT Perfusion V1.0 | Olea Medical | LLZ | Class II | |
| K222450 | LVIS NeuroMatch | Lvis Corporation | OMB | Class II | |
| K220498 | NovoGen Wound Matrix | Novabone Products, LLC | KGN | Unclassified | |
| DEN220078 | Eroxon | Futura Medical Developments Limited | QWW | Class II | |
| K231350 | OCD MT Cap (85-00397-000) | Neuronetics Inc. | QCI | Class II | |
| K231042 | Disposable Laparoscopic Trocar | Changzhou Ankang Medical Instruments Co., Ltd. | GCJ | Class II | |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co.,Ltd. | PTI | Class II | |
| K230659 | Zionic Aesthetic | Termosalud | PBX | Class II | |
| K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences LLC | QAQ | Class II | |
| K230008 | Ablamap® System | Ablacon, Inc. | DQK | Class II | |
| K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | Philips Medical Systems Nederland B.V. | DQK | Class II | |
| K222792 | SNUCONE Tissue Level Implant System | Snucone Co., Ltd. | DZE | Class II | |
| K222762 | Siddharth-Ii;impact | Panacea Medical Technologies Pvt., Ltd. | IYE | Class II | |
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi | Howmedica Osteonics Corp | NKB | Class II | |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd | OAB | Class II | |
| K214124 | AlloX2 Pro Tissue Expanders | Sientra, Inc. | LCJ | Unclassified | |
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings dba Intimate Rose | HDX | Class II | |
| K231360 | Ambra PACS | DICOM Grid (dba Ambra Health) | LLZ | Class II | |
| K231322 | Fix2Lock(PEEK Self Punching) | Osteonic Co., Ltd. | MBI | Class II | |
| K231170 | C350/C350G LCD Monitor; M550/M550G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K231002 | Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) | Suzhou Endophix Co., Ltd. | MBI | Class II | |
| K230691 | HyperVue™ Imaging System | Spectrawave, Inc. | NQQ | Class II | |
| K230651 | BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) | Becton Dickinson & Co | JTN | Class II | |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | KWS | Class II | |
| K230446 | TiLink-L SI Joint Fusion System | Surgentec LLC | OUR | Class II | |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | CS Medical LLC | PSW | Class II | |
| K223059 | Xenco Medical InterAlign Cervical Interbody System | Xenco Medical LLC | OVE | Class II | |
| K222248 | Infrared Thermometer | Alicn Medical Shenzhen, Inc | FLL | Class II | |
| K213611 | Fenom Pro | Caire Diagnostics, Inc. | MXA | Class II | |
| K212183 | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | JPA | Class II | |
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | NJM | Class II | |
| K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC | LZA | Class I | |
| K230660 | AviClear Laser System | Cutera Inc | GEX | Class II | |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | OWQ | Class II | |
| K230329 | F3D Interbody System | Corelink, LLC | ODP | Class II | |
| K230261 | Gnesis EMS Plus | Creative Fitness Developments SL | NGX | Class II | |
| K230005 | Pantheris LV Atherectomy Catheter | Avinger, Inc. | MCW | Class II | |
| K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | Feops NV | QIH | Class II | |
| K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | LLZ | Class II | |
| K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | MWI | Class II | |
| K212734 | Diode laser therapy device | Triangel RSD Limited | GEX | Class II | |
| K212733 | Diode laser therapy device | Beijing Star New Tech Co., Ltd. | GEX | Class II | |
| DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | QWB | Class II | |
| K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | Roche Diagnostics GmbH | QSE | Class II | |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | Zhenjiang Assure Medical Equipment Co Ltd | IOR | Class I | |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Medical | DHA | Class II | |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies ULC (A Part of Stryker) | IZI | Class II | |
| K230633 | APOLLO ADVANTAGE Nitrile Examination Gloves | Dell Corning Corporation | LZA | Class I | |
| K230498 | ArtiSential Laparoscopic Instruments-Electrodes | LivsMed Inc. | GEI | Class II | |
| K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | NJM | Class II |