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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K130503 | Pathassist LED Light Fiber | Entellus Medical, Inc. | LRC | Class I | |
| K130025 | Sonendo Endotherapy System | Sonendo Inc | ELC | Class II | |
| K123520 | Mammomat Inspiration Prime | Siemens Medical Solutions USA, Inc. | MUE | Class II | |
| K123292 | T3 | Medcomp | NIE | Class II | |
| K122748 | Engler 25K Series Ultrasonic Inserts | Engler Engineering Corp. | ELC | Class II | |
| K122521 | Prevent Seal | Itena Clinical | EBC | Class II | |
| K131380 | Acumed Totalw Rist Fusion Plating System | Acumed LLC | HRS | Class II | |
| K130907 | Hoffmann Lrf (Limb Reconstruction Frame) System | Stryker Trauma GmbH | KTT | Class II | |
| K124023 | Starband | Orthomerica Products, Inc. | OAN | Class II | |
| K120892 | Disposable 330Psi Extension Lines | Coeur, Inc. | DXT | Class II | |
| K131300 | The Powerwand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | DYB | Class II | |
| K131217 | S Test Reagent Cartridge Total Bilirubin | Canon Medical Diagnostics USA, Inc. | CIG | Class II | |
| K131115 | Zerowire Duo Wireless Hd Video Transfer System, or Zero Wire | NDS Surgical Imaging, LLC | GCJ | Class II | |
| K131112 | Limacorporate Smr Cta Humeral Heads | Lima Corporate S.p.A. | KWS | Class II | |
| K131051 | Hitachi S Test Reagent Cartridge Total Protein (Tp) and Albumin (Alb) | Canon Medical Diagnostics USA, Inc. | JGQ | Class II | |
| K130944 | Isr'obot Mona Lisa | Biobot Surgical Pte. Ltd. | IYO | Class II | |
| K130791 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | DRE | Class II | |
| K130726 | Da Vinci Single-Site Permanent Cautery Hook | Intuitive Surgical, Inc. | NAY | Class II | |
| K130636 | Teleradpro Edge; Teleradpro Edge Hd-Ccd | Vidar Systems Corp. | LMA | Class II | |
| K130464 | Carestream Drx-1 System with Drx 2530C Detector | Eastman Kodak Company | MQB | Class II | |
| K130446 | Fastbraces Ceramic Brackets | Orthodontic Design and Production, Inc. | NJM | Class II | |
| K130259 | Bearing Nspva Embolization Particles | Merit Medical Systems, Inc. | NAJ | Class II | |
| K130185 | 4Web Osteotomy Bone Wedge | 4-Web, Inc. | HRS | Class II | |
| K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control Set | Diazyme Laboratories, Inc. | DDR | Class II | |
| K123576 | Imr Software Application | Philips Healthcare (Cleveland) | JAK | Class II | |
| K123105 | Xgeo Gu60 | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge Ast | Canon Medical Diagnostics USA, Inc. | CKA | Class I | |
| K131346 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | |
| K131329 | Vector Pta Balloon Dilatation Catheter | R4 Vascular, Inc. | LIT | Class II | |
| K131103 | Xres Blood Collection Reservoir Xres 120Micrometer Blood Collection Reservoir | Corcym Inc. | DTN | Class II | |
| K130739 | Acuson S2000 and S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K130645 | Aquilion Prime, V5.00 | Toshibamedical Systems Corporation | JAK | Class II | |
| K130149 | U2 Hip System, Expanded Indications for Use | United Orthopedic Corp. | LPH | Class II | |
| K123481 | Aquacel Ag Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non Adhesive | ConvaTec Limited | FRO | Unclassified | |
| K123394 | Coreleader Hydro-Healer Hydrocolloid Wound Dressing | Coreleader Biotech Co., Ltd | FRO | Unclassified | |
| K121902 | Natratone | Orelle Corporation, Ltd. | HIR | Class II | |
| K121642 | Wizard 230 Nasal Pilow Mask | Apex Medical, Inc. | BZD | Class II | |
| K121436 | Das Medical Equipment Drapes | Das Medical, LLC | KKX | Class II | |
| K120931 | Critical Care Ventilator | Oricare Inc. | CBK | Class II | |
| K131321 | Cd Horizon Spinal System | Medtronic Sofamor Danek USA Inc | OSH | Class II | |
| K130773 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Ltd. | MWI | Class II | |
| K130599 | Wart Freeze | Koninklijke Utermohlen NV | GEH | Class II | |
| K130598 | Inspirachamber Anti-Static Valved Holding Chamber | Inspirx, Inc. | NVP | Class II | |
| K130427 | Pioneer Aspect Anterior Cervical Plate System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | Class II | |
| K130382 | Heartstring III Proximal Seal System | Boston Scientific Corporation | DXC | Class II | |
| K130328 | F&p Simplus Full Face Mask | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K123843 | Neuroepg System | Strohl Medical Technologies | GWF | Class II | |
| K123518 | Abbott Carbamazepine Assay | Microgenics Corporation | KLT | Class II | |
| K123423 | Illumigene Mycoplasama DNA Amplification Assay, and Illumigene Mycoplasma External Controls Kit | Meridian Bioscience Inc | OZX | Class II | |
| K123101 | Trc-50Dx Retinal Camera | Topcon Healthcare, Inc. | HKI | Class II |