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 |
|---|---|---|---|---|---|
| K001751 | Medis 2Mp2 Quad-Head Medical Diagnostic Display System | Barco NV Display Systems | LLZ | Class II | |
| K001746 | Lightsheer Pulsed Diode Array Laser System (Family of Products) | Coherent Star | GEX | Class II | |
| K001723 | Cool-Tec Electrodes | Seedling Enterprises., LLC | GEI | Class II | |
| K001716 | Redon Set | Pfm Produkte Fur die Medizin AG | JCX | Class II | |
| K001630 | Ksea Bipolar Coagulating Electrodes | Karl Storz Endoscopy-America, Inc. | GWG | Class II | |
| K001511 | O-Las Ophthalmic Photodisruptor | A.R.C. Laser GmbH | GEX | Class II | |
| K001361 | Jilco Traction-Flexion Chair | Jilco Enterprises | ITH | Class II | |
| K000944 | Thermage Thermacool System | Solta Medical, Inc. | GEI | Class II | |
| K000869 | La Personal Scooter | Assembled Products Corp. | INI | Class II | |
| K993686 | Light Patch | Bioscan, Inc. | ILY | Class II | |
| K993685 | Biopack | Bioscan, Inc. | ILY | Class II | |
| K993328 | Surgilight, Inc Excimer Laser | Surgilight, Inc. | GEX | Class II | |
| K992182 | Ca Guard, Ltd. Psp (Port Site Protector) | Ca Guard, Ltd. | GCJ | Class II | |
| K001964 | Optimum Cleaning, Disinfecting and Storage Solution | Lobob Laboratories, Inc. | MRC | Class II | |
| K001843 | S.m.a.r.t. Nitinol Stent Transhepatic Biliary System | Cordis US Corp. | FGE | Class II | |
| K001612 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K001573 | Sensititre 18-24 Hours Susceptibility Plates | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K001450 | Auto Suture Micro Surgiclip Clip Applier | United States Surgical, A Division of Tyco Healthc | FZP | Class II | |
| K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | DSI | Class II | |
| K001298 | J.a.g. Lightweight Manual Wheelchair | Roll-Ability (Pty), Ltd. | IOR | Class I | |
| K994018 | Pharmaseed, Model Bt-125-3 | Syncor Pharmaceuticals, Inc. | KXK | Class II | |
| K993996 | Univec Auto-Disable Hypodermic Syringe | Univec, Inc. | MEG | Class II | |
| K001904 | Arthrocare Flow Control Unit | ArthroCare Corporation | GEI | Class II | |
| K001730 | Gc Fujicem | GC America Inc. | EMA | Class II | |
| K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159 | Cogent Light Technologies, Inc. | FFS | Class II | |
| K001582 | Liberty 9000 Breast Coil with Disposable Biopsy Plate | GE Healthcare Coils | MOS | Class II | |
| K001386 | Accuset Sensor, Model 2000 | Pelvicare, Inc. | FEN | Class II | |
| K001370 | Accusonic Plus, Model Ap-100 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | |
| K001362 | Karl Storz 3D Video System | Karl Storz Imaging, Inc. | GCI | Class II | |
| K001328 | Introducer Sheath | Novasys Medical, Inc. | FEC | Class II | |
| K001296 | Spinal Cord and Immobilization Traction System | Cavendish Scott, Inc. | ITH | Class II | |
| K001276 | Medical Image Merge (Mim) | Syntermed, Inc. | KPS | Class II | |
| K001268 | Ge Marquette Prism Information Server Applications | General Electric Medical Systems Information Techn | MHX | Class II | |
| K001236 | Riza Band Stretcher (Rbs)-60000 | R-Med, Inc. | FHN | Class II | |
| K994016 | Pharmaseed, Model Bt-103-3 | Syncor Pharmaceuticals, Inc. | KXK | Class II | |
| K001924 | Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content Labeling Claim (50 Microgram or Less0 | Medtronic, Inc. | KGO | Class I | |
| K001271 | Samarco Spider Plates | Zimmer GmbH | KTW | Class II | |
| K994413 | Brainscan | Brainlab, Inc. | MUJ | Class II | |
| K993674 | Pocket Ultrasonic Pachymeter | Quantel Medical | IYO | Class II | |
| K002003 | Hdi 5000 Ultrasound System with Extended Field of View Imaging | Atl Ultrasound, Inc. | IYN | Class II | |
| K001906 | Elecsys Insulin Calset | Roche Diagnostics GmbH | JIS | Class II | |
| K001747 | Medis 2Mp2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | LLZ | Class II | |
| K001729 | Focus | Instrumentarium Corp. | EHD | Class II | |
| K001583 | Island Biosurgical Bns Kit #3 | Island Biosurgical, Inc. | KOD | Class II | |
| K001275 | Retcam II | Massie Research Laboratories, Inc. | HKI | Class II | |
| K001265 | Welch Allyn Instrument Interface Module | Welch Allyn Inc | MWI | Class II | |
| K001242 | Isolette Infant Incubator, Model C2hs | Hill-Rom Air-Shields | FMZ | Class II | |
| K000647 | Datex-Ohmeda Network and Central | GE Healthcare | MSX | Class II | |
| K993248 | Amplatzer Sizing Balloon | Abbott Medical | MJN | Class II | |
| K001891 | Microsample Coagulation Analyzer, Model Mca 310-C | Bio/Data Corp. | GKP | Class II |