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 |
|---|---|---|---|---|---|
| K062521 | Oxalate Urine Controls (Normal and Elevated) | Thermo Electron Oy | JIT | Class II | |
| K062433 | Diamics Cercol Cervical Sample Collector System | Diamics, Inc. | HHT | Class II | |
| K062306 | Plasmacon N, Plasmacon L-1, Plasmacon L-2 | R2 Diagnostics, Inc. | GGC | Class II | |
| K061489 | Atrilaze Mi Surgical Ablation System | Medical Cv, Inc. | GEX | Class II | |
| DEN070004 | Xpert Ev, Model Gxev-100N-10; Genexpert Dx System, Models P/n 900-0144, 900-0145, 900-0146, 900-0065 | Cepheid | OAI | Class II | |
| K070539 | Mortara Eli 10 Electrocardiograph | Mortara Instrument, Inc. | DPS | Class II | |
| K070522 | Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012 | Abbott Diagnostics Scarborough, Inc. | MJH | Class II | |
| K070496 | Advacoat Sinus Gel and Stent | Carbylan Biosurgery | LYA | Class I | |
| K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | LZO | Class II | |
| K070472 | Clever Chek Td-4230 Blood Glucose Monitoring System, Rd-4230, Surechek Blood Glucose Monitoring System, Sms-4230 | Taidoc Technology Corporation | NBW | Class II | |
| K070448 | Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model Ads-1001 | Cardiomems, Inc. | NQH | Class II | |
| K070340 | Secure Arterial Blood Sampling System | Abbott Medical | CBT | Class I | |
| K070072 | Non-Chlorinated Polymer Coated Powder-Free Natural Latex Examination Gloves | Medtexx Manufacturing Sdn. Bhd. | LYY | Class I | |
| K070048 | Guardian Catheter-Infant Urinary Collection Kit | Marian Medical, Inc. | FCM | Class II | |
| K063875 | Stryker Foot Plating System | Howmedica Osteonics Corp | HRS | Class II | |
| K063844 | Reprocessed Heart Stabilizers and Positioners | Sterilmed Inc | NQG | Class I | |
| K063645 | Frequencer, Model 1001 | Dymedso, Inc. | BYI | Class II | |
| K063581 | Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non Sterile | Pt Mahakarya Inti Buana | LYY | Class I | |
| K063490 | Spacelabs Medical Full Disclosure System, Model 91810 | GE Healthcare | DQK | Class II | |
| K063210 | Attain Hybrid Guide Wires, Model Gwr419378, Gwr419388, Gwr419478, Gwr419488 | Medtronic Inc. Cardiac Rhythm Management | DQX | Class II | |
| K062820 | Unity Alpha System | Bonutti Research, Inc. | HWC | Class II | |
| K062651 | Prochem Ext Chemical Integrator | Raven Biological Laboratories, Inc. | JOJ | Class II | |
| K062222 | Unitip High Resolution Catheter | Unisensor AG | FFX | Class II | |
| K070538 | Xp Bond Dual Cure Universal Total Etch Adhesive | Dentsply Intl. | KLE | Class II | |
| K070489 | Heartway Power Tilt Seating System Power Chair, Model# P16rt | Heartway Medical Products Co., Ltd. | ITI | Class II | |
| K070350 | P&f Power Wheelchair, Hc-510 | P & F Brother Ind., Corp. | ITI | Class II | |
| K070279 | Modification to Hypertransit Infusion Catheter | Cordis Neurovascular, Inc. | KRA | Class II | |
| K070262 | Ertapenem Antimicrobial Susceptibility Test Disc | Oxoid, Ltd. | JTN | Class II | |
| K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K070096 | Powder Free Nitrile Examination Gloves, Blue, White, Pink, Black and Gray Color | Gx Corporation Sdn Bhd | LZA | Class I | |
| K063859 | Surgiquest Elastomeric Optical Trocar & Cannula | Surgiquest, Inc. | GCJ | Class II | |
| K063775 | Elia Gliadin Iga, Igg and Celiac Control | Phadia AB | MST | Class II | |
| K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec | DZE | Class II | |
| K063353 | Ctbox Cervical/lumbar Traction | Circular Traction Supply, Inc. | ITH | Class II | |
| K063227 | Conceivex Conception Kit | Conceivex, Inc. | OBB | Class II | |
| K062479 | Joykey Surgical Gowns (Sterile) | Joykey Industryial, Ltd. | FYA | Class II | |
| K062327 | Modification to S4 Spinal System | Aesculap Inc | NKB | Class II | |
| K062203 | Tina-Quant D-Dimer Test System | Roche Diagnostics GmbH | GHH | Class II | |
| K061881 | Osteotrans -Mx Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | JEY | Class II | |
| K070421 | Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02 | GE Healthcare | MSX | Class II | |
| K070285 | Life Spine Anterior Cervical Plate System | Life Spine | KWQ | Class II | |
| K070223 | Audit Microcv Lipids Linearity Set (Low) | Aalto Scientific Ltd. | JJY | Class I | |
| K063618 | Tenderflow Periatric Arterial Cannula | Terumo Cardiovascular Systems Corporation | DWF | Class II | |
| K063352 | Ellex Slit Lamp, Model 30Xl | Takagi Seiko Co., Ltd. | HJO | Class II | |
| K063248 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | NDN | Class II | |
| K062872 | Synthes (USA) Pediatric Lcp Hip Plate System | Synthes (USA) Products LLC | JDS | Class II | |
| K060832 | Retro-Tech Dressing | Retro-Tech, LLC | FRO | Unclassified | |
| K060452 | Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015Xx-Ecah | Neo-Genesis | JLX | Class I | |
| K053342 | Gengigel Mouthrinse | Ricerfarma SRL | OLR | Unclassified | |
| K070308 | Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear | X-Cel Contacts | LPL | Class II |