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 |
|---|---|---|---|---|---|
| K003913 | Hint Audiometer, or Hint | MAICO Diagnostics GmbH | EWO | Class II | |
| K003449 | E Motion Wheelchair Drive System (Power-Assist for Manual Wheelchairs) | Ulrich Alber GmbH | ITI | Class II | |
| K002706 | Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer on Hitachi | Roche Diagnostics GmbH | DAP | Class II | |
| K002254 | Cook Pressure Monitoring Catheter | Cook Inc. | DQO | Class II | |
| K992706 | Galix Gbi -3S-Lp | Galix Biomedical Instrumentation, Inc. | MLO | Class II | |
| K010631 | Nemio | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K010617 | Spife Ife Calibrator and Control Kit | Helena Laboratories, Corp. | DEW | Class II | |
| K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | ODG | Class II | |
| K010523 | Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen Test | Binax, Inc. | GTZ | Class I | |
| K010463 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires | GE Healthcare | DQA | Class II | |
| K010447 | Modification to Acticoat Foam Dressing | Westaim Biomedical, Inc. | FRO | Unclassified | |
| K010427 | Lorenz Fiducail Screw | Biomet Microfixation | HAW | Class II | |
| K010425 | Epidural Catheter with Connector (and Accessory) | Hdc Corp. | KNF | Class II | |
| K010351 | Inion Cps Baby 1.5 Bioabsorbable Fixation System | Inion Oy | JEY | Class II | |
| K010116 | Planmed Sophie, Planmed Sophie Classic | Planmed Oy | IZH | Class II | |
| K010103 | Surshield Winged Infusion Set | Terumo Medical Corp. | FPA | Class II | |
| K010085 | EEG Real Patient Spike and Event Detector Module, Model Ex-Sp-Rp (Proposed) | Excel Tech., Ltd. | OMB | Class II | |
| K010070 | Ultrapak Neha | Ultradent Products Inc. | MVL | Unclassified | |
| K004050 | Panasonic Tele-Homecare System | Matsushita Electric Industrial Co., Ltd. | MWI | Class II | |
| K003955 | Laserex Integre, Model Lp2532 | Ellex Medical Pty Ltd | GEX | Class II | |
| K003899 | Ifis-Sa Integrated Fuctional Imaging System | Mri Devices Corp. | LNH | Class II | |
| K003557 | Acon Thc One Step Marijuana Test Strip(urine);acon Thc One Step Marijuana Test Device (Urine) | Acon Laboratories, Inc. | LDJ | Class II | |
| K003501 | N Protein Standard Uy Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K003346 | Randox Glucose (God/pap) | Randox Laboratories, Limited | CGA | Class II | |
| K003344 | Medical Depot Nebulizer, Model Power Neb 2 | Medical Depot Inc. | CAF | Class II | |
| K003301 | Diffmaster Octavia Automatic Hematology Analyzer | Cellavision AB | JOY | Class II | |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model Crs126-a | Sigma Diagnostics, Inc. | DAP | Class II | |
| K002315 | Wisebands Skin Closure Device | Wisebands, Ltd. | MKY | Class I | |
| K002297 | Yoramed, Model T-202 | United Yoram Distributors, Inc. | GZJ | Class II | |
| K010687 | Biosorbfx and Biosorbpdx Mesh | Bionx Implants, Inc. | JEY | Class II | |
| K010402 | Smooth-Flo Circuit | Hudson Respiratory Care, Inc. | BTT | Class II | |
| K010359 | Innovo | Novo Nordisk a/S | FMF | Class II | |
| K010352 | Cps 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion Oy | JEY | Class II | |
| K010191 | Y2000 Pocket Rescue | Cheen Houng Ent. Co. Ltd. | CBP | Class II | |
| K010061 | Dimension Clinical Chemistry System, Model Xpand | Siemens Healthcare Diagnostics Inc. | CEM | Class II | |
| K010024 | O2/co2 Nasal Filterline | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K002382 | 'All 2000' % Oxygen Analyzer | Analytical Industries, Inc. | CCL | Class II | |
| K010562 | Alpha Dx System | First Medical, Inc. | MMI | Class II | |
| K010437 | Modification to Ebi Xfix Dfs Rail System | Ebi, LLC | KTT | Class II | |
| K010434 | Optetrak B-Series Total Knee System | Exactech, Inc. | JWH | Class II | |
| K010428 | Accutni Qc on the Access Immunoassay System #33349 | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K010405 | 7230 Ultrasound Imaging System with Tei | Esaote North America, Inc | IYN | Class II | |
| K010373 | Simplicity Soft Y Infusion Set for Use with the Minimed Infusion Pumps and Minimed Medication Reservoirs (Model Mmt-103) | Sterling Medivations, Inc. | FPA | Class II | |
| K010062 | Styrofoam Cutters for Block Casting System | Arplay Medical S.A. | IYE | Class II | |
| K004015 | Beam Block Trays | Arplay Medical S.A. | IYE | Class II | |
| K003947 | Functional Brain Mapping Option for MRI | GE Healthcare | LNH | Class II | |
| K003911 | Terray Stainless Steel Rod (Straight, L, Rectangle) | Terray Corp. | KWP | Class II | |
| K003746 | 3D-Doctor | Able Software Corp. | LLZ | Class II | |
| K003614 | Lightsheer Pulsed Diode Array Laser System | Coherent Star | GEX | Class II | |
| K003503 | N Latex Cystatin C | Siemens Healthcare Diagnostics Inc. | NDY | Class II |