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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K260716 | Neowise | Cefla S.C. | LLZ | Class II | |
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OLI | Class II | |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K254115 | ArteraAI Breast | Artera | SHW | Class II | |
| K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | OMP | Class II | |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies SLU | GEX | Class II | |
| K252954 | MammoSightAI | NEUROCAREAI Inc (dba SaveLife.AI) | QFM | Class II | |
| K252622 | Male Latex Condom HA | Okamoto U.S.A., Inc. | HIS | Class II | |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | Amsino International, Inc. | FPA | Class II | |
| K261074 | Biomonitor IV (471155) | BIOTRONIK AG | MXD | Class II | |
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co.,Ltd. | FMK | Class II | |
| K260910 | EndoTool IV Cloud 1.0 | Glooko Inc | NDC | Class II | |
| K260819 | Any-Com Seal | Mediclus Co., Ltd | EBC | Class II | |
| K260314 | Ancora-SB | Aspero Medical, Inc. | FDA | Class II | |
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | FTC | Class II | |
| K254154 | FX V135 EASYTECH® Shoulder System | Fx Shoulder Solutions Inc. | PKC | Class II | |
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | OCC | Class II | |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | HWC | Class II | |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | NKB | Class II | |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | DQA | Class II | |
| K253663 | Zeta Navigation System | Zeta Surgical Inc. | HAW | Class II | |
| K253326 | Oxiplex | Fziomed, Inc. | QVL | Class II | |
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Medtronic, Inc. | CCK | Class II | |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | MBI | Class II | |
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals ApS | CGA | Class II | |
| K252475 | ABL90 FLEX PLUS System | Radiometer Medicals ApS | JGS | Class II | |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co.,LTD. | GXY | Class II | |
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | LBH | Class II | |
| DEN240075 | Prolystica Pass Thru Disinfectant Wipes | STERIS Corporation | SHM | Class II | |
| K261404 | UltraEZ | Ultradent Products Inc. | LBH | Class II | |
| K261067 | BEE PLIF Cage | Ngmedical GmbH | MAX | Class II | |
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co.,Ltd | GTY | Class I | |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | Orthopediatrics Corp | HRS | Class II | |
| K254189 | Synapse 3D Base Tools (V7.2) | FUJIFILM Corporation | QIH | Class II | |
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | QFG | Class II | |
| K253436 | c-med0 alpha | Cosinuss GmbH | MWI | Class II | |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co.,Ltd | IRP | Class II | |
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | QSY | Unclassified | |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | GCJ | Class II | |
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | BYI | Class II | |
| K252503 | Intelligent NR | Canon, Inc. | OWB | Class II | |
| K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | QQJ | Class II | |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | CAH | Class II | |
| K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | SAK | Class II | |
| DEN250023 | Aurie System | Cathbuddy, Inc. | SHV | Class II | |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K261086 | Break Wave | Sonomotion, Inc. | LNS | Class II | |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | DYB | Class II | |
| K260589 | ES-Series | E-Scopics | IYN | Class II | |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | QIH | Class II |