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 |
|---|---|---|---|---|---|
| K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | OEB | Class II | |
| K213891 | RealNow | Yiwei Medical Technology Co., Ltd. | LLZ | Class II | |
| K213805 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | NPK | Class II | |
| DEN220065 | Pill Sense System | Enterasense Limited | QUD | Class II | |
| DEN220063 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | QVD | Class II | |
| K230241 | Jumong General | SG Healthcare Co Ltd | KPR | Class II | |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | HQF | Class II | |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | FTL | Class II | |
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Stryker Corp. | GCJ | Class II | |
| K230212 | OrthoButton AL | Riverpoint Medical, LLC | MBI | Class II | |
| K223797 | Neuro20 Pro System | NEURO20 Technologies Corp. | NGX | Class II | |
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd | OHS | Class II | |
| K223262 | Renuvion® APR Handpiece | Apyx Medical Corporation | GEI | Class II | |
| K223233 | Monaco RTP System | Elekta Solutions AB | MUJ | Class II | |
| K223229 | MOSAIQ® OIS (Oncology Information System) | Elekta Solutions AB | IYE | Class II | |
| K223216 | Symphony Thrombectomy System | Truvic Medical, Inc. | QEW | Class II | |
| K223209 | Elekta Unity | Elekta Solutions AB | IYE | Class II | |
| K223161 | OXY-1 System | Abiomed, Inc. | DTZ | Class II | |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | MNR | Class II | |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | Schoelly Fiberoptic, GmbH | GCJ | Class II | |
| K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | POK | Class II | |
| K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 | StringKing | FYA | Class II | |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | MSX | Class II | |
| K230371 | The Alma Soprano Titanium | Alma Lasers Ltd. | GEX | Class II | |
| K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc | LNH | Class II | |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | Pajunk GmbH Medizintechnologie | HAW | Class II | |
| K230197 | BoneMRI v1.6 | Mriguidance B.V. | QIH | Class II | |
| K230180 | Rosa Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K223492 | eFOLDi Scooter, Lite | Suntech UK Limited | INI | Class II | |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co Ltd | LYY | Class I | |
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | LNS | Class II | |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | EFB | Class I | |
| K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) | Medtronic, Inc. | GAG | Class II | |
| K221469 | PATI (Protector Against Tongue Injury) | Neurovice | JXL | Class II | |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | HKI | Class II | |
| K212587 | 3D-Rd-S | Radiopharmaceutical Imaging & Dosimetry, LLC | IYX | Class I | |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co.,Ltd. | QRL | Class II | |
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | Ranfac Corp. | KNW | Class II | |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Abbott Medical | QLG | Class II | |
| K222259 | NEONA 1.5T MRI System | Time Medical Limited | LNH | Class II | |
| K222184 | Introducer Sheath Kits | Beijing Demax Medical Technology Co., Ltd. | DYB | Class II | |
| K214068 | Quantia IgE | Biokit, S.A. | DGC | Class II | |
| K213348 | BOND MMR Antibody Panel | Leica Biosystems Newcastle Ltd. | PZJ | Class II | |
| K221861 | FloNavi Endoscopic Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | ONF | Class II | |
| K223897 | Excipio LV Thrombectomy Device | Contego Medical, Inc | QEW | Class II | |
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd | LLZ | Class II | |
| K223798 | Glidewell TuffSplint™ Appliance Resin | Prismatik Dentalcraft, Inc. | MQC | Unclassified | |
| K223545 | APRO 70 Catheter and Alembic Aspiration Tubing | Alembic LLC | NRY | Class II |