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 |
|---|---|---|---|---|---|
| K013151 | Asmotom Automated Trephine System | Bkg Opthalmics USA, Inc. | HRG | Class I | |
| K013094 | Orthosonix Energex | Orthosonix, Inc. | NHH | Class II | |
| K012820 | Aia-Pack Ctni 2Nd-Gen Assay | Tosoh Medics, Inc. | MMI | Class II | |
| K011197 | Dermaclear UV-B Phototherapy System | Lumenis Ltd | FTC | Class II | |
| K013992 | Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) Immunoassay | Nichols Institute Diagnostics | CEW | Class II | |
| K013935 | Allofit Acetabular System 32Mm Alpha Durasul Inserts | Sulzer Orthopedics, Inc. | LZO | Class II | |
| K013842 | Immuno-Trol Low Cells | Siemens Healthcare Diagnostics Inc. | JPK | Class II | |
| K013815 | Medrad Qwik-Fit Syringe | Medrad, Inc. | DXT | Class II | |
| K013801 | Ultrasafe Dental Injection System | Safety Syringes, Inc. | MEG | Class II | |
| K013739 | Modification to Ebi Xfix Dfs System | Ebi, LLC | LXT | Class II | |
| K013528 | Crystal 5000 Phases Array Tmj Coil | GE Healthcare Coils | MOS | Class II | |
| K013516 | Invacare Elevating Seat Option Ess6 | Invacare GmbH | ITI | Class II | |
| K013493 | Indigo Optima Laser System | Ethicon Endo-Surgery Inc | GEX | Class II | |
| K013367 | Cardiocollect Portable Electrocardiograph | Reynolds Medical, Ltd. | DPS | Class II | |
| K013358 | Dynapulse 5000A Mini Abp Blood Pressure Monitoring System | Pulse Metric, Inc. | DXN | Class II | |
| K013337 | Prizm Keratome Blade (Nidek Model), Model Mk8514ni | Surgin, Inc. | HNO | Class I | |
| K013334 | Endoflip | Arthocare Corporation | MBI | Class II | |
| K013271 | Dxs Digital X-Ray System | Douglas C. Yoon, Dds | MUH | Class II | |
| K013242 | Amsco Harmony Surgical Lighting and Media System | STERIS Corporation | FTD | Class II | |
| K013092 | Hi-Toque Whisper Ls and Ms Guide Wire with Hydrocoat Hydrophilic Coating | Boston Scientific Corporation | DQX | Class II | |
| K013090 | Sopro 67D Operating Room Camera | Sopro | GCJ | Class II | |
| K013086 | Wet Light Personal Moisturizer | Trigg Laboratories, Inc. | HIS | Class II | |
| K012686 | Caird Technology Holter 2000 | Caird Technology | DPS | Class II | |
| K012378 | 3D Humeral Heads | Smith & Nephew, Inc. | KWS | Class II | |
| K011454 | Spine Scope, Model 2180 | Clarus Medical, LLC | HRX | Class II | |
| K010526 | Modification to the Grip | Elcare Innovations, Inc. | LIX | Class II | |
| K004008 | Stress Guard, Model Herdev1 | Herbo Medex International, Inc. | GZJ | Class II | |
| K013807 | Microjet Quark, Model U100 or U40 | Cane S.r.l. | LZG | Class II | |
| K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, from an External Infusion Pump | Sterling Medivations, Inc. | FRN | Class II | |
| K013580 | Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Susceptibility Plate | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K013423 | Microscan Dried Gram Negative Overnight Mic/combo Panels | Dade Microscan, Inc. | JWY | Class II | |
| K013411 | Pulpdent Cavity Preparation IV | Pulpdent Corporation | LBH | Class II | |
| K013379 | Sas Strepalert | SA Scientific, Ltd | GTY | Class I | |
| K013076 | Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator | Siemens Healthcare Diagnostics Inc. | LEH | Class II | |
| K013071 | Securcut Aspiration Biopsy Needle | H.S. Hospital Services S.p.A. | FCG | Class II | |
| K013070 | Jamshidi Biopsy Needle | H.S. Hospital Services S.p.A. | FCG | Class II | |
| K013069 | Biospeed | H.S. Hospital Services S.p.A. | FCG | Class II | |
| K013890 | Surgical Dynamics Meniscal Staple | United States Surgical, A Division of Tyco Healthc | HWC | Class II | |
| K013792 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K013788 | Travel Ease Electric Scooter, Model Pioneer 5 | Merits Health Products, Inc. | INI | Class II | |
| K013344 | Intera I/t | Philips North America LLC | LNH | Class II | |
| K013246 | Datex-Ohmeda S/5 Network and Central '01 | GE Healthcare | MSX | Class II | |
| K013066 | Hx-5/6-1 Endoscopic Clipping Device | OLYMPUS Corporation of the Americas | MND | Class II | |
| K013063 | Grip Lock Anchor, Model 411374 | Medtronic Neuromodulation | GZB | Class II | |
| K012762 | Mjs Posterior Stabilized Knee System | Osteoimplant Technology, Inc. | HRY | Class II | |
| K012587 | RF Generators, Disposable Cartridge Kit, Disposable Cartridge, Reusable Handle, Disoisable Handpiece Reusable Telescope | Vidamed, Inc. | KNS | Class II | |
| K012583 | Acuglide Brand Acupuncture Needles | Helio Medical Supplies, Inc. | MQX | Class II | |
| K012501 | H.m.t. Acupuncture Needle | Hummingbird Medical Technology, LLC | MQX | Class II | |
| K010443 | Capiox Sx10 Hollow Fiber Oxygenator With/without Hardshell Reservoir with X-Coating | Terumo Cardiovascular Systems Corporation | DTZ | Class II | |
| K010388 | Sondrex P.a.l. System | GE Healthcare | HCC | Class II |