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 |
|---|---|---|---|---|---|
| K022195 | Coamatic at-400 | Instrumentation Laboratory Co. | JBQ | Class II | |
| K021877 | Mda D-Dimer | bioMerieux, Inc. | GHH | Class II | |
| K021508 | Opusduo Ec Dental Laser System | Opusdent, Ltd. | GEX | Class II | |
| K021492 | K-Y Brand Warming Liquid Personal Lubricant | Personal Products Co., Div. of Mcneil Ppc, Inc. | NUC | Class II | |
| K020357 | 800 Series Easyneb Nebulizer | Medtronic, Inc. | CAF | Class II | |
| K020312 | Ultima Snoring Mike, Model 0540 | Braebon Medical Corp. | MNR | Class II | |
| K013396 | Alpha Drive System | Alpha Omega, Ltd. | HAW | Class II | |
| K022428 | Quantitative Blood Pool Spect (Qbs) | Philips North America LLC | LLZ | Class II | |
| K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | KWQ | Class II | |
| K022281 | Safe Maxi Venous/cardiotomy Reservior, Model 016045 | Polystan A/S | DTN | Class II | |
| K022248 | Stryker L3 Hydrolert | Stryker Corp. | FLN | Class II | |
| K022240 | Mobile Millennium Mg System | GE Healthcare | KPS | Class II | |
| K022209 | Alaris Medical Infusion System Administration Sets | CareFusion 303, Inc | FPA | Class II | |
| K022065 | Sintea Biotech Traumafix System, Model Tfx.00.00.x | Sintea Biotech, Inc. | JEC | Class II | |
| K022054 | F 900 | Cso | HKY | Class II | |
| K021974 | Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311 | Minimed, Inc. | MRZ | Class II | |
| K021753 | E-Care Infared Ear Thermometer, Model Lct-200 | E-Care Technology Corporation | FLL | Class II | |
| K021702 | Cryobag, Model Cb | OriGen Biomedical, Inc. | LPZ | Unclassified | |
| K021644 | Perf (Ommaya Style) Reservoirs | Phoenix Biomedical Corp. | JXG | Class II | |
| K021542 | Adc Dental | Agfa Corp. | MUH | Class II | |
| K021511 | Cytoflex Mesh | Unicare Biomedical, Inc. | JEY | Class II | |
| K021496 | Hms-Dhr-3 Neuromuscular Stimulator | Home Medical Services | GZJ | Class II | |
| K021481 | Bresagen Catheter, Model Cs-3000 | Bresagen, Inc. | HCA | Class II | |
| K021472 | Hms-Dhr-3 Neuromuscular Stimulator | Home Medical Services | IPF | Class II | |
| K020897 | Rossmax Automatic Wrist Blood Pressure Monitor, Models B150 & Q400 | Rossmax Internationl, Ltd. | DXN | Class II | |
| K020520 | Easytem Ear Thermometer, Model Bt-020 | Metatech Corp. | FLL | Class II | |
| K013999 | Lodox, Model Baseline | Lodox Systems (Pty) Ltd. | JAK | Class II | |
| K010805 | Prisma System | Gambro Renal Products | KDI | Class II | |
| K022434 | Bard Ultraview Multiple Band Ligator, Model 00700U | C.R. Bard Inc | MND | Class II | |
| K021855 | Top Glove Powderfree Latex Examination Glove with Protein Labelling Claims (50 Micrograms or Less) | Top Glove Sdn. Bhd. | LYY | Class I | |
| K021386 | Poly Stat Hcg Dipstick Test | Alidex, Inc. | JHI | Class II | |
| K021357 | Medpor Plus Orbital Volume Replacement Impant | Porex Surgical, Inc. | HPZ | Class II | |
| K020672 | Elecsys Anti-Tg Test System | Roche Diagnostics GmbH | JZO | Class II | |
| K013704 | Mediplus Single Use Gi Manometry Catheter | Mediplus Ltd. | KLA | Class II | |
| K001755 | Mpw Hemodialysis Water Purification System | Mpw Industrial Water Services, Inc. | FIP | Class II | |
| K022476 | Relyx Rmgip | 3M Company | EMA | Class II | |
| K022317 | Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-St, & Soft-Release-R Infusion Sets | Sooil Development Co., Ltd. | LZG | Class II | |
| K022246 | Modification to Symphony Graft Delivery System | Depuyacromed | FMF | Class II | |
| K022101 | Medtexx Powderfree Nitrile Rubber Examination Gloves, Green Colour | Latexx Manufacturing Sdn.Bhd. | LZA | Class I | |
| K021725 | Disetronic D-Tron Insulin Infusion Pump | Disetronic Medical Systems | LZG | Class II | |
| K021617 | C.t.m. Power Chair, Model Hs-2800 | C.T.M. Homecare Product, Inc. | ITI | Class II | |
| K021455 | Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782, | Boston Scientific Corporation | DQY | Class II | |
| K021440 | Bonesource Hac | Stryker Corp. | GXP | Class II | |
| K020150 | Crc-15Bt | Mirion Technologies (Capintec), Inc. | KPT | Class II | |
| K020120 | Endovive Initial Placement Direct Pej Kit, Endovive Standard Profile Balloon Replacement, Models 6520, 6521, 6220 | Boston Scientific Corporation | KNT | Class II | |
| K014023 | Baby Teether, Model 20104 | Angelina Trading, Inc. | KKO | Class II | |
| K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical | KCT | Class II | |
| K022310 | Advantage Windows X-Ray/mr Fusion | GE Healthcare | LLZ | Class II | |
| K022232 | Cliniqa Liquid-Qc Hcg Control Level 1, 2, and 3 | Cliniqa Corporation | JJX | Class I |