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 |
|---|---|---|---|---|---|
| K010681 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | KWP | Class II | |
| K003709 | Surgical Dynamics Mesh Cage System | United States Surgical, A Division of Tyco Healthc | MQP | Class II | |
| K003364 | Vivo 200 Dps Vivoscan | Vivosonic Inc. | EWO | Class II | |
| K011982 | 0.9% Sodium Chloride Injection, Usp Bd Pre-Filled Flush Syringe | BD | FOZ | Class II | |
| K011884 | Powdered Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | |
| K011883 | Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | |
| K011853 | Abbott Tumormarker-Mcc (Lyophilized), Levels 1 and 2, 2Ml No. 6E21-10 | Bio-Rad | JJY | Class I | |
| K011712 | Latex Examination Gloves- Powder Free, Blue | Pt.Shamrock Manufacturing Corp. | LYY | Class I | |
| K011596 | Urea Nitrogen (Bun) Liquid Reagent | Jas Diagnostic, Inc. | CDQ | Class II | |
| K011581 | Ameritek Brachytherapy Template | Amertek Medical, Inc. | ITX | Class II | |
| K011499 | Visualine Amphetamine Dipstrip Assay | Sun Biomedical Laboratories, Inc. | DKZ | Class II | |
| K011456 | Delta Plus Multiaction Solution for Rigid Gas Permeable Contact Lenses | Sauflon Pharmaceuticals, Ltd. | MRC | Class II | |
| K011264 | Mesh Ureteral Stent | Applied Medical Resources Corp | FAD | Class II | |
| K011256 | Toric Lite Lens | Soflex Contact Lens Industries, Ltd. | LPL | Class II | |
| K011112 | Cyclosporine Calibrator | Siemens Healthcare Diagnostics Inc. | DLJ | Class II | |
| K003966 | Wundcath Conduction Catheter | Micor, Inc. | FRN | Class II | |
| K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | JWH | Class II | |
| K011955 | Modification To:accusonic Plus, Model Ap-100 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | |
| K011885 | Synthetic Powder Free Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | |
| K011628 | Concord 82 | Gateway Alloys, Inc. | EJT | Class II | |
| K011626 | Concord 72 | Gateway Alloys, Inc. | EJT | Class II | |
| K011525 | Safe at Home Tsh (Thyroid Stimulating Hormone Blood Collection and Transport System) | Biosafe Laboratories, Inc. | JLW | Class II | |
| K011419 | Cavex Colorchange | Cavex Holland B.V. | ELW | Class II | |
| K011402 | Biopsy Site Marker | Senorx, Inc. | FZP | Class II | |
| K011189 | Viaduct Microendoscope and Accessories | Acueity, Inc. | GCJ | Class II | |
| K011076 | Lorenz Sternal Closure System with Modular Screw | Biomet Microfixation | HRS | Class II | |
| K010008 | Axxess Spinal Cord Stimulation Lead, Model 8000 Series, Including 80Xx, 81Xx, and 82Xx | Micronet Medical, Inc. | GZB | Class II | |
| K012013 | Lifesource Models Ua-787, Ua 787Pc, Ua-787T | A and D Engineering, Inc. | DXN | Class II | |
| K012006 | Medical Depot Power Neb 1 | Medical Depot Inc. | CAF | Class II | |
| K011993 | Quantum Blast | Pride Mobility Products Corp | ITI | Class II | |
| K011965 | Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 | Boston Scientific Corporation | KOD | Class II | |
| K011948 | Hoffman II Hybrid Ring Clamp | Howmedica Osteonics Corp | LXT | Class II | |
| K011942 | Aequalis Press-Fit Shoulder Prosthesis | TORNIER Inc. | HSD | Class II | |
| K011910 | In-Fast Bone Screw System | American Medical Systems, Inc. | HWC | Class II | |
| K011847 | Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable | Zynergy Cardio Vasular (Zcv), Inc. | DRF | Class II | |
| K011837 | Lifecard Cf 7 Day | Reynolds Medical, Ltd. | MWJ | Class II | |
| K011779 | Avidcare Series 100 Telemanagement System | Avid Care Corp. | DXN | Class II | |
| K011515 | Medline Grounding Pad | MEDLINE INDUSTRIES, LP - Northfield | JOS | Class II | |
| K011429 | Model 100 Activity Monitor | Telecom Medical, Inc. | GYD | Class II | |
| K011401 | Rambler | Rambler Mobility, Inc. | INI | Class II | |
| K011257 | Endopath Non-Bladed Obturator Trocar System (5 Mm) | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K011078 | Malleable Shaft Clamp | Medtronic, Inc. | DXC | Class II | |
| K010600 | Suprema Powered Wheelchair | Luigi Chinetti | ITI | Class II | |
| K010051 | Poly-Tapes with the Fastlok Fixation Device | Xiros Ltd | JDR | Class II | |
| K004043 | Metal Transcend Articulation System | Wrightmedicaltechnologyinc | JDL | Class III | |
| K983024 | Proton Therapy System | Ion Beam Applications S.A. | LHN | Class II | |
| K012097 | Vortex | Ultravisual Medical Systems | LLZ | Class II | |
| K012072 | Voxar Vc, Model 1.0 | Voxar Limited | LLZ | Class II | |
| K012017 | Variseed 7.0 | Varian Medical Systems, Inc. | MUJ | Class II | |
| K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio | Abbott Medical | FMI | Class II |