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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K052840 | Igi-System | Denx Advanced Dental Systems | HAW | Class II | |
| K052799 | Multitak 6.0 Mm Absorbable Anchor System | Bonutti Research, Inc. | MAI | Class II | |
| K052744 | C2000 Automated Manifold Kit | Acist Medical Systems, Inc. | DXT | Class II | |
| K052727 | Rossmax Non-Invasive Blood Pressure Monitors, Models S380, K350 | Rossmax International Ltd. | DXN | Class II | |
| K052694 | One Step Hcg Pregnancy Test - 2000 Miu/ml, Model 100 Series. | Ind Diagnostic, Inc. | JHI | Class II | |
| K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20 | Biospace Inc. | MNW | Class II | |
| K052604 | Starlite 2006 | Laser Dental Innovations | GEX | Class II | |
| K052597 | Breathex Omega CPAP Device, Model 322 | Hoffman Laboratories, LLC | BZD | Class II | |
| K052386 | Medtronic M2 Magnet Adjustment Tool | Medtronic Neurosurgery | JXG | Class II | |
| K052307 | Beamer Painlow Infrared Light Treatment System | Beamline Corporation | ILY | Class II | |
| K052303 | Readmyheart, Model Rmh2.0 | Dailycare Biomedical, Inc. | DPS | Class II | |
| K052263 | Multiple (Tooth Desensitizer) | Cosmedent, Inc. | LBH | Class II | |
| K052160 | Acuity Central Station, Model 020Xxxxx (Note: Xxxxx = Various Config.) | Welch Allyn Inc | DSI | Class II | |
| K052120 | Lumimed Monochrome Lcd Monitor, Models Mm 20, Mm 30 and Mm50 | Heeyoung Co., Ltd. | LLZ | Class II | |
| K052081 | Remote Access Perfusion (Rap) Femoral Venous Cannula | Estech, Inc. | DWF | Class II | |
| K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.s.e. Module) | Horiba Abx | CFR | Class II | |
| K051896 | Model 750E Series Monitor | Cas Medical Systems, Inc. | MWI | Class II | |
| K051781 | Graftcage Tlx | Osteotech Inc | MQP | Class II | |
| K051386 | Mastergraft Putty Bone Void Filler | Medtronic, Inc. | MQV | Class II | |
| K051195 | Grafton Dbm | Osteotech Inc | MBP | Class II | |
| K043598 | Fc 1400 Fetal Monitor | Bionet Co., Ltd. | HGM | Class II | |
| K043597 | Fc 700 Fetal Monitor | Bionet Co., Ltd. | HGM | Class II | |
| K053392 | Futurabond Nr Single Dose | Voco GmbH | KLE | Class II | |
| K053296 | Mentor Aris Suprapubic Surgical Kit | Mentor | OTN | Class II | |
| K053250 | Ans 90 Cm and 110 Cm (3100 and 3200 Series) Lead Kit | Abbott Medical | GZB | Class II | |
| K053197 | Trufill Dcs Orbit Detachable Coil System Line Extension | Cordis Neurovascular, Inc. | HCG | Class II | |
| K053173 | Ds Cassette | Konica Minolta Medical & Graphic, Inc. | IXA | Class II | |
| K052943 | Ddrformula and Ddrformula Plus | SWISSRAY Medical, AG | KPR | Class II | |
| K052912 | Yusheng Disposable Vaginal Speculum | Zhejiang Yusheng Medical Instrument Co., Ltd. | HIB | Class II | |
| K052632 | Vitrea2 Version 3.8 Medical Image Processing Software | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K052606 | Marietta Contact Lens (Polymacon), Tinted Daily Wear Contact Lens | Orion Vision | LPL | Class II | |
| K052338 | Solar Gi | Medical Measurement Systems B.V. | FFX | Class II | |
| K051828 | Nipro Surefuser Ambulatory Infusion Pump | Nipro Medical Corporation | MEB | Class II | |
| K051433 | I-Stat Creatine Kinase Mb (Ck-Mb) | I-Stat Corp. | MYT | Class II | |
| K053394 | Nexa Bone Screw System | Nexa Orthopedics, Inc. | HWC | Class II | |
| K053199 | Synthes Patient Specific Cranial/craniofacial Implant | Synthes (USA) Products LLC | GXN | Class II | |
| K053165 | Ise Indirect Na, K, Cl for Gen.2 | Roche Diagnostics GmbH | JGS | Class II | |
| K053146 | Quickvue Influenza a + B Test | Ortho-Clinical Diagnostics, Inc. | PSZ | Class II | |
| K053141 | Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800 | Magstim Inc. | ETN | Class II | |
| K053097 | Vitek 2 Gram Positive Cefoxitin Screen | bioMerieux, Inc. | LON | Class II | |
| K053011 | Pro-Neo Neonatal ECG Electrode, Models Sg15 and Sr20 | Bio Protech, Inc. | DRX | Class II | |
| K052724 | Teco Ise Reagent Set for Cx System | Teco Diagnostics | JGS | Class II | |
| K052645 | Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products Fs Calibrator 1, Ref 6801873; | Ortho-Clinical Diagnostics, Inc. | GTQ | Class I | |
| K052531 | Fu Hong Industries Limited Soother Teether | Fu Hong Industries, Ltd. | KKO | Class II | |
| K052503 | Troponin I Ultra Assay and Calibrator for the Advia Ims System | Medrad, Inc. | MMI | Class II | |
| K052259 | Dr. Scholl's Dual Action Freeze Away Wart Remover, Model 40406 | Schering-Plough Healthcare Products, Inc. | GEH | Class II | |
| K052087 | Breathing Filter Bacterial/viral, Model Ag7178 | AG Industries LLC | CAH | Class II | |
| K053365 | Modification to Thermage Thermacool System | Solta Medical, Inc. | GEI | Class II | |
| K053282 | Adaptable Monopolar Electrodes with Ceramic Tip | Pajunk GmbH Medizintechnologie | GEI | Class II | |
| K053149 | Spiro-Ball | Leventon, S.A. | BWF | Class II |