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 |
|---|---|---|---|---|---|
| K951894 | Access Expansion System | Micro Medical Devices, Inc. | FHO | Class II | |
| K951839 | Aladan Hypoallergenic Latex Medical Examination Gloves | Aladan Corp. | LYY | Class I | |
| K951670 | Disposable Latex Patient Examination Gloves | Emi Groups (U.S.A.), Inc. | LYY | Class I | |
| K951585 | T-Uptake Calibrators | Diagnostic Reagents, Inc. | JIS | Class II | |
| K951479 | Catheterization Insertion Pack Urological, Sterile, Disposable | Trinity Laboratories, Inc. | FCM | Class II | |
| K951462 | Amo Profinesse III Ultrasonic Handpiece System | Advanced Medical Optics, Inc. | HQC | Class II | |
| K951443 | Standard Foley System Pak | Trinity Laboratories, Inc. | FCN | Class II | |
| K951341 | Neitz Slit Lamp Sl-H2 | Neitz Instruments Company, Ltd. | HJO | Class II | |
| K950418 | Alpha Porous Coated Femoral Component (Subject to Wmti Marketing Approval) | Wrightmedicaltechnologyinc | JDI | Class II | |
| K950215 | Acutome(r) 150 Multi-Wavelength Color-Corrected(tm) Laser Handpiece | Reliant Laser Corp. | GEX | Class II | |
| K946290 | Citation Power Tool | Citation Medical Corp. | HRX | Class II | |
| K946271 | Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed & Undyed, Braided and Monofilamt | Ethicon, Inc | GAM | Class II | |
| K946169 | Actic 2002 | North Atlantic Rehabilitation, Inc. | BXB | Class I | |
| K945820 | Desra | D.S.R.A., Inc. | LQZ | Class II | |
| K945427 | B-D Digital Thermometer | BD Becton Dickinson Vacutainer Systems Preanalytic | LHD | Unclassified | |
| K943571 | Multi-Level Control for Fibrin Degradation Products | More Diagnostics Inc. | DAP | Class II | |
| K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | DXT | Class II | |
| K912035 | Stainless Steel Green Vena Cava Filt W/12f Intr Sy | Boston Scientific Corporation | DTK | Class II | |
| K952577 | Electrosurgical Dispersive Electrode | Medtrex, Inc. | GEI | Class II | |
| K952335 | Wound Care Management Kits | Continental Medical Laboratories, Inc. | LYY | Class I | |
| K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | CGA | Class II | |
| K952259 | Storz Microseal Dp8030 & Dp8045 Phacoemulsification Needles | Storz Instrument Co. | HQC | Class II | |
| K951988 | Pressurizer | Promedic, Inc. | KZD | Class I | |
| K951969 | Myoexorciser II Fual | Verimed Holdings, Inc. | HCC | Class II | |
| K951789 | Palliag Nf IV | Degussa AG | EJT | Class II | |
| K951602 | Pulse*spray Infusion System | Angiodynamics, Div. E-Z-Em, Inc. | KRA | Class II | |
| K951519 | Weco Endoscopic System with Fiber Optic Light | Wells Johnson Co. | FWL | Class I | |
| K951354 | Olympus Arthroscopy System | OLYMPUS Corporation of the Americas | HRX | Class II | |
| K951230 | Microsurge Bipolar Graspers | Microsurge, Inc. | GEI | Class II | |
| K951190 | Karl Storz Puncture, Injection, Endoscopic, Veress Needle | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K951088 | Quest Retrograde Cardiplegia Cannula-Rccs | Quest Medical, Inc | DWF | Class II | |
| K950375 | Disposable & Reusable Bipolar Suction Coagulator | Boston Surgical Products, Inc. | GEI | Class II | |
| K950234 | Total Protein Test (Tpro) Item Number: Xxxxx/r1. R2 | EMD Millipore Corporation | CEK | Class II | |
| K950077 | Intraoperative Corneal Topography System (I-Cts) | Par Vision Systems Corp. | MMQ | Class I | |
| K946198 | Impla-Med Low Margin Abutments, Screwdriver, Polishing Protector | Sterngold | DZE | Class II | |
| K946112 | Elastomeric Sleep Appliance | Village Park Orthodontics | LQZ | Class II | |
| K945684 | Poc Arthroscope and Accessories | Precision Optics Corp. | HRX | Class II | |
| K945298 | Smartflow I Administration Set | River Medical, Inc. | FPA | Class II | |
| K942529 | Hci Tube Stabilizer | Health Care Contracts, Inc. | CBH | Class I | |
| K941393 | Iti Angled Abutment | Straumann USA, LLC | DZE | Class II | |
| K934590 | Improved Passivation Method for Metallic Orthopaedic Implants | Smith & Nephew Richards, Inc. | HWC | Class II | |
| K931801 | Multi-Dop X | Dantec Medical, Inc. | IYO | Class II | |
| K930298 | Rogozinski Spinal Rod System Screw | Smith & Nephew Richards, Inc. | MNH | Class II | |
| K952075 | Progesterone Assay for the Technicon Immuno 1 System in-Bitro Diagnostic System | Bayer Corp. | JLS | Class I | |
| K952029 | Rusch International Urodynamic Catheters | Rusch Intl. | FEN | Class II | |
| K951796 | Ciba Corning Acs Thyroid Stimulating Hormone (Tsh-3) Immunoassay | Ciba Corning Diagnostics Corp. | JLW | Class II | |
| K951539 | Enterococcus Screening Medium | Becton Dickinson Microbiology Systems | JWY | Class II | |
| K951490 | Lasevac | D.D. Surgical, Inc. | HET | Class II | |
| K951478 | General and Plastic Surgery Packs | Sterile Concepts, Inc. | LRO | Class II | |
| K951189 | Synchron Cx4ce/cx5ce/cx7 Clinical Systems Software Update Version 4.0 | Beckman Instruments, Inc. | JJE | Class I |