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 |
|---|---|---|---|---|---|
| K063172 | Arthrocare Cavity Spinewand | ArthroCare Corporation | GEI | Class II | |
| K063038 | Fraxel III Sr Laser System and Accessories | Reliant Technologies, Inc. | GEX | Class II | |
| K070886 | Merogel Injectable Bioresorbable Stent | Medtronic, Inc. | NHB | Class II | |
| K070664 | Progeny Imaging Software, Model# 500-405 (6,7,8). | Progeny, Inc. | MUH | Class II | |
| K070498 | Hyper Sal | Pari Innovative Manufacturers, Inc. | CAF | Class II | |
| K070455 | Zoll E Series with See-Thru CPR | ZOLL Medical Corporation | MKJ | Class III | |
| K070413 | Ascent Universal Adhesive, Model 006-00028 | Cao Group, Inc. | KLE | Class II | |
| K070292 | Durom Hip Resurfacing System, Femoral Components | Zimmer GmbH | KXA | Class II | |
| K070249 | Abx Pentra 400, Calcium Cp, Creatinine Cp, Phosphorus Cp, Amylase Cp, Urine Control L/h | Horiba Abx | CIC | Class II | |
| K063582 | Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, Xlarge | Zimmer GmbH | KGO | Class I | |
| K063391 | Sapheneia Clarity | Sapheneia Commercial Products AB | LLZ | Class II | |
| K070948 | Hsiner Nebulizer Bottle | Hsiner Co., Ltd. | CAF | Class II | |
| K070848 | Liquichek Urinalysis Control (Bi-Level), Control Level1, Level 2,Minipak, 435,436,437,435X | Bio-Rad, Diagnostics Grp. | JJW | Class I | |
| K070700 | Freealgin | Zhermack S.p.A. | ELW | Class II | |
| K070618 | Dicompacs, Model 5 | Oehm und Rehbein GmbH | LLZ | Class II | |
| K070474 | Newlife Sciences Llc, Model Tmr | Newlife Sciences, LLC | GZJ | Class II | |
| K070381 | Theken Vu Mesh Vbr System | Theken Companies LLC | MQP | Class II | |
| K070374 | Arthrocare ENT Plasma Wand | ArthroCare Corporation | GEI | Class II | |
| K063380 | Echostim Facet Tip | Havel's, Inc. | BSP | Class II | |
| K062332 | Altaire Mps#1 Multipurpose Contact Lens Solution | Altaire Pharmaceuticals, Inc. | LPN | Class II | |
| K070896 | Enseal Ptc Tissue Sealing Device | Surgrx, Inc. | GEI | Class II | |
| K070879 | Bard Malecot and Pezzer Drains | C.R. Bard Inc | FEW | Class II | |
| K070839 | Modification to Capiox Flexible Venous Reservoir | Terumo Cardiovascular Systems Corporation | DTN | Class II | |
| K070776 | Supra Ophthalmic Laser Photocoagulator | Quantel Medical | HQF | Class II | |
| K070711 | Incircle Bi-Polar RF Ablation System | Rfa Medical, Inc. | GEI | Class II | |
| K070606 | Visio+cd Viewer# Kpscdve01 | Keosys SAS | LLZ | Class II | |
| K070589 | C! | Transphoton Corporation | KPS | Class II | |
| K070535 | Retropan Ccd-Twain-Usb | Video Dental Concepts, Inc. | MUH | Class II | |
| K070521 | Modified Mercy Retriever, Model 90070 | Concentric Medical, Inc. | NRY | Class II | |
| K070398 | Hospira Plum a+ Infusion Pump, Model 12391 | Abbott Medical | FRN | Class II | |
| K070330 | Third Eye Retroscope Auxiliary Endoscopy System | Avantis Medical Systems, Inc. | FDF | Class II | |
| K070311 | Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261 | Medtronic, Inc. | GEI | Class II | |
| K070231 | Orion | Nidek Technologies SRL | HKI | Class II | |
| K070222 | Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610N | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K063708 | 4S Spinal System | Taeyeon Medical Co., Ltd. | MNI | Class II | |
| K063636 | Zilos-Tk | Hamilton Thorne Biosciences | MRX | Class II | |
| K063286 | Osseotite; Osseotite Nt; Xp; Tg Osseotite | ZimVie US Corp LLC | DZE | Class II | |
| K062834 | Osteon, Models Gbg0305, Gbg0510, Gbg1020, Gbg2030, Gbg3040, Gbg4050 | GENOSS Co., Ltd. | LYC | Class II | |
| K060747 | Fx Detachable Coil System | Medtronic, Inc. | HCG | Class II | |
| K070958 | Modification to Arthrocare Arthrowands | ArthroCare Corporation | GEI | Class II | |
| K070747 | Quick Vue Rsv Test, Models 20193, 20199 | Ortho-Clinical Diagnostics, Inc. | GQG | Class I | |
| K070203 | Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and 130024 | Inviro Medical Devices, Inc. | MEG | Class II | |
| K070106 | Vv Fluoro 3D | Brainlab, Inc. | HAW | Class II | |
| K070004 | Accent | Alma Lasers Ltd. | GEI | Class II | |
| K063766 | Transferrin Tia , Calibrator Set, Control-L,control-M,control-H, Model# Kt-0105-A,ca-0105-A,b,c | Good Biotech Corp. | DDG | Class II | |
| K063758 | Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier (Remanufacturer), Model# 425-00,425-00R | Teleflex Medical | BTT | Class II | |
| K063745 | Medilaser, Model 1000 | Laser Thera, LLC | ILY | Class II | |
| K062105 | Diazyme Creatinine Liquid Reagents Assay | Diazyme Laboratories, Inc. | JFY | Class II | |
| K070976 | Rii Infrared Ear Thermometer, Model Th01bn | Radiant Innovation Inc. | FLL | Class II | |
| K070954 | Patientgallery Imaging Software | Raster Builders, Inc. | LLZ | Class II |