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 |
|---|---|---|---|---|---|
| K992955 | Xplorer 1000 | Imaging Dynamics Company, Ltd. | MQB | Class II | |
| K990519 | Phoenix Epidural & Spinal Needles | Myco Medical Supplies Inc | BSP | Class II | |
| K001458 | Synchron Control | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K001435 | Viking Optima Guiding Catheter | Boston Scientific Corporation | DQY | Class II | |
| K001427 | Modification to Fasttake Compact Blood Glucose Monitoring System | Selfcare, Inc. | CGA | Class II | |
| K001422 | Psn Hemodialyzer, Models Psn 170, Psn 210 | Baxter Healthcare Corporation | KDI | Class II | |
| K001413 | Elox 45-Bp, Model 330 132, Efh-27, Model 331 549, Extension Tool, Model 331 668 | BIOTRONIK AG | DTB | Class III | |
| K001341 | Dr5000 Dedicated Chest X-Ray System | Analogic Corp. | KPR | Class II | |
| K001336 | Dr9000 Digital Radiography X-Ray System | Analogic Corp. | KPR | Class II | |
| K001285 | Ammonia-L3k Assay, Model 263-17, Ammonia-L3k Assay, Model 263-30 | Sekisui Diagnostics P.E.I. Inc. | JIF | Class I | |
| K001058 | Audioscreener Oae + Abr | Kedly, Inc. | EWO | Class II | |
| K001017 | Retrax Retracting Needle Syringe, Size 3Cc | Retrax Safety Systems, Inc. | MEG | Class II | |
| K000164 | Complete Brand Comfortplus Multi-Purpose Solution | Allergan | LPN | Class II | |
| K994116 | Laser System Mediostar H (with and without Skin Cooling System) | Aesculap-Meditec North America | GEX | Class II | |
| K993775 | Sterrad Bi Test Pack | Advanced Sterilization Products | FRC | Class II | |
| K001490 | Hardydisk Cefonicid, 30 Mcg | Hardy Diagnostics | JTN | Class II | |
| K001489 | Hardydisk Cefoperazone, 75 Mcg | Hardy Diagnostics | JTN | Class II | |
| K001209 | Insight Plus 9000 Phased Array Torso and Pelvis Coil | GE Healthcare Coils | MOS | Class II | |
| K001201 | Multix Compact K and Multix L Radiographic X-Ray Systems | Siemens Medical Solutions USA, Inc. | KPR | Class II | |
| K001014 | Elecsys Anti-Tpo Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K001005 | Wako Hdl-C/ldl-C Calibrator | FUJIFILM Healthcare Americas Corporation | JIS | Class II | |
| K001004 | Wako Apolipoprotein High Level Calibrator | FUJIFILM Healthcare Americas Corporation | JIS | Class II | |
| K000987 | Vfss Imager, Model Sis-300 | Lifecare Imaging Intl., Ltd. | JAA | Class II | |
| K000976 | Diamond (Mammographic X-Ray System) | Instrumentarium Imaging, Inc. | IZH | Class II | |
| K000769 | Ksea Manhes Pneumotrocar | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K000766 | Tri-Fix Spinal Fixation System | Endius, Inc. | MNI | Class II | |
| K000463 | Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg | Siemens Healthcare Diagnostics Inc. | LYR | Class I | |
| K000456 | Harvest Technologies Dual Liquid Applicator, Model Sk/s: Harvest Dual Liquid Applicator Lk/2 | Terumo BCT, Ltd | FMF | Class II | |
| K994274 | Quest Mps Perfusion Assisted Direct Coronary Artery Bypass (Padcab) | Quest Medical, Inc | FRN | Class II | |
| K993528 | Rusch Emergency Mask | Rusch, Inc. | CBP | Class II | |
| K991103 | Modification to Acist Cl 100H | Acist Medical Systems, Inc. | DXT | Class II | |
| K990331 | Surgen Valve | Tiva Medical | FPA | Class II | |
| K984231 | Angiographic Contrast Management System, Model Part a and Part B | Invasatec | DXT | Class II | |
| K983068 | Reliance Family of Washer-Disinfectors | STERIS Corporation | LDS | Class II | |
| K001367 | Fast-Cath 18F Hemostasis Introducer, Model 406Xxx | Abbott Medical | DYB | Class II | |
| K993991 | Hm-930 Electrosurgical Unit | Hill-Med, Inc. | GEI | Class II | |
| K993010 | Bara-Med, Acrylic Monoplace Hyperbaric Chamber | Environmental Tectonics Corp. | CBF | Class II | |
| K001330 | Sovereign Bipolar Instruments | Aesculap Inc | GEI | Class II | |
| K001302 | Arthrocare System 2000 Controller, Arthrocare System 2000 Cable, Arthrocare System 2000 Footswitch, Plasma Scalpel Gs, C | ArthroCare Corporation | GEI | Class II | |
| K001264 | Eagle Endo Specimen Retrieval Bag | Eagle Endoscopic, Inc. | GCJ | Class II | |
| K001108 | Prime-Dent Visible Light Cure Composite Restorative Material | Prime Dental Manufacturing, Inc. | EBF | Class II | |
| K000720 | Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector Cable | Somnus Medical Technologies, Inc. | GEI | Class II | |
| K000719 | Neocare 20 Micron Blood Filter | Whatman, Inc. | CAK | Class II | |
| K994329 | Iivs Integrated Image Viewing Station | Terarecon, Inc. | LMD | Class I | |
| K994260 | Candela Gentlelase Gl Dermatological Laser | Candela Corporation | GEX | Class II | |
| K992668 | Innerdyne Radially Expanding Vascular Access System (Revas) | Innerdyne, Inc. | DYB | Class II | |
| K001429 | Modification to Accudexa Bone Densitometer | Schick Technologies, Inc. | KGI | Class II | |
| K001428 | Optimum Wetting and Rewetting Drop | Lobob Laboratories, Inc. | MRC | Class II | |
| K001397 | Quickscreen Pro Drug Cup, Model 9195X | Phamatech Inc. | DKZ | Class II | |
| K001315 | Modification to Kion Anesthesia System | Siemens Elema AB | BSZ | Class II |