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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K163032 | Kyphon Xpede Bone Cement | Medtronic, Inc. | NDN | Class II | |
| K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) | MEDLINE INDUSTRIES, LP - Northfield | LZA | Class I | |
| K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | Exactech, Inc. | KWT | Class II | |
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System | Aesculap Inc | JXG | Class II | |
| K170257 | Sydney IVF Culture Oil | William A. Cook Australia Pty, Ltd. | MQL | Class II | |
| K170218 | Vesco Medical NRFit Tip Syringes | Vesco Medical LLC | FMF | Class II | |
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FOZ | Class II | |
| K163480 | Renamel NANO +plus | Cosmedent, Inc. | EBF | Class II | |
| K163056 | Revolution™ Spinal Fixation System | Intelligent Implant Systems, LLC | NKB | Class II | |
| K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | EZL | Class II | |
| K162916 | 3NT endoscopy system | 3NT Medical Ltd. | EOB | Class II | |
| K162888 | Cercon | Dentsply Sirona Inc | EIH | Class II | |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | Btg International, Inc. | QEY | Class II | |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | LifeCell Corp | FTM | Class II | |
| K162393 | The ViewRay (MRIdian) Linac System | Viewray Systems, Inc. | IYE | Class II | |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | Hager & Meisinger GmbH | DZE | Class II | |
| K162071 | IllumiFlow Laser Cap | Eglobal, LLC | OAP | Class II | |
| K161860 | TG-970P CO2 Sensor Kit | Nihon Kohden Corp. | CCK | Class II | |
| K161859 | MagnetOs | Xpand Biotechnology BV | MQV | Class II | |
| K161579 | Watch-PAT200U | Itamar Medical | MNR | Class II | |
| K161484 | ZIIP Device | Ziip,Llc | NFO | Class II | |
| K161372 | The Red Head Collection Device, The Jordy Connection System | Miami Fat Supply, Inc | MUU | Class II | |
| K161371 | Sonoma Fifth Metatarsal Repair System | Sonoma Orthopedic Products, Inc. | HSB | Class II | |
| K160857 | HF 718BD X-Ray System | Arquilla, Inc. dba X-Cel X-Ray Corporation | KPR | Class II | |
| K160358 | Dt-100 | Mediana Co., Ltd. | FLL | Class II | |
| K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor | Wrightmedicaltechnologyinc | MBI | Class II | |
| K170240 | Truliant Femoral Components | Exactech, Inc. | JWH | Class II | |
| K170209 | ImPACT | Impact Applications, Inc. | POM | Class II | |
| K163688 | Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 | Medisono, LLC | IYN | Class II | |
| K163322 | TZ SKULL PIN Adult | TZ Medical Inc. | HBL | Class II | |
| K163279 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA Inc | KCT | Class II | |
| K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) | Hebei Hongtai Plastic Products Co.,Ltd. | LYZ | Class I | |
| K162937 | Stryker OrthoMap Versatile Hip System | Stryker Corp. | OLO | Class II | |
| K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | EFB | Class I | |
| K162922 | GalaFORM 3D | Tepha, Inc. | OOD | Class II | |
| K162855 | Reveal LINQ | Medtronic, Inc. | MXD | Class II | |
| K162827 | Vidas B.r.a.h.m.s. Pct (Pct) | bioMerieux, Inc. | PRI | Class II | |
| K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | MUE | Class II | |
| K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K161907 | Pressure Therapy System | Xiamen Senyang Co., Ltd | IRP | Class II | |
| K161848 | Family of Steam sterilizers B17 B22 Series | Cefla S.C. | FLE | Class II | |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | Stryker Sustainability Solutions | NLQ | Unclassified | |
| K161607 | Visulux | Carl Zeiss Meditec Inc | HJO | Class II | |
| K161335 | Dual Top Screw System | Jeil Medical Corporation | OAT | Class II | |
| K161316 | George King Coumadin Plasma | George King Bio-Medical, Inc. | GGN | Class II | |
| K161099 | Powder Free Nitrile Examination Gloves, Black | P.T. Maja Agung Latexindo | LZA | Class I | |
| K160837 | Medinet Incentive Spirometers - Respiprogram | Medinet SRL | BWF | Class II | |
| DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | Accelerate Diagnotics | PRH | Class II | |
| K170202 | Aquarius 8600 | Imaging Dynamics Company, Ltd. | MQB | Class II | |
| K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II |