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 |
|---|---|---|---|---|---|
| K003858 | Modification to at Home Drug Test, Models 9150, 9068, and 9175 | Phamatech Inc. | MVO | Unclassified | |
| K003829 | Total Bilirubin | JAS Diagnostics/Drew Scientific | CIG | Class II | |
| K003767 | Asserachrom Hpia Test Kit | Diagnostica Stago, Inc. | LCO | Class II | |
| K003668 | Autodelfia Neonatal Irt Kit, Model B005-112 | Wallac Oy | CGZ | Class II | |
| K003571 | Serono for Use with Gonal-F 1200Iu Multi-Dose Only at 600Iu/ml Syringe | Terumo Medical Corp. | FMF | Class II | |
| K003567 | Serenocem, Model Bc 010 | Corinthian Medical, Ltd. | NEA | Class II | |
| K003529 | Sonolith Praktis, Endourology Table Praktis | Edap Technomed Inc. | LNS | Class II | |
| K003526 | Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty 55 UV Multifocal (Methafilcon) | Specialty Ultravision, Inc. | LPL | Class II | |
| K003515 | Echo View/shimasonic Diagnostic Ultrasound System, Model Sdu-1200 | Shimadzu Medical Systems | IYN | Class II | |
| K003514 | Echo View/shimasonic Diagnostic Ultrasound System, Model Sdu-2200 | Shimadzu Medical Systems | IYN | Class II | |
| K003510 | Instatrak System with Fluorocat, Model It3500 | Visualization Technology, Inc. | LLZ | Class II | |
| K002083 | Lorenz Resorbable Distractor System | Biomet Microfixation | JEY | Class II | |
| K993856 | Tuttnauer Electronic Autoclave, Models E, Ea, Ek, Eka, Ep | Tuttnauer USA Co. Ltd. | FLE | Class II | |
| K010282 | Lateral Offset Protract Press Fit Hip Stem | Globus Medical, Inc. | LPH | Class II | |
| K010231 | Jk Gloves Pre-Powdered Latex Examination Glove | Jk Gloves Sdn. Bhd. | LYY | Class I | |
| K010179 | Ebi Vuecath Spinal Endoscopic System | Ebi, LLC | HRX | Class II | |
| K010150 | 64 Channel EEG / Model Number Ex-Nw-64 | Excel Tech., Ltd. | GWQ | Class II | |
| K010121 | Sterile Button Plate | Synthes (USA) Products LLC | MBI | Class II | |
| K010120 | Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set Neck Segment, M-Series Low Off-Set Neck S | Exactech, Inc. | LPH | Class II | |
| K010102 | Sonic Model So-300 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | |
| K010095 | Nonsterile Powdered Purple Latex Examination Gloves, with & without Grape Scent with Protein Labeling (200 Micrograms or | Sgmp Co., Ltd. | LYY | Class I | |
| K010044 | Cosmic | Jeneric/Pentron, Inc. | EJT | Class II | |
| K003985 | Powderfree Nitrile Patient Exmination Glove | Guthrie Medicare Products (Melaka) Sdn Bhd | LZA | Class I | |
| K003800 | Aml Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K003743 | Synthes Modified Bioresorbable Suture Anchor System | Synthes (USA) Products LLC | MAI | Class II | |
| K003540 | (Disposable) Vaginal Speculum | Feminica, Inc. | HIB | Class II | |
| K003499 | Remview Sleep Recorder, Model 320 | Respironics, Inc. | LEL | Class II | |
| K003493 | 3I Calcium Sodium Phosphate Bone Cement | Zimmer GmbH | LYC | Class II | |
| K010241 | Protract Press Fit Hip Stem-Ha Coated | Globus Medical, Inc. | LPH | Class II | |
| K010190 | Wristwatch Blood Pressure Monitor, Model A43 | Rossmax Internationl, Ltd. | DXN | Class II | |
| K010068 | Rusch Polyflex Stent for the Esophagus with Introducer System | Rusch Intl. | ESW | Class II | |
| K003940 | 2010 Plus Holter for Windows | Agilent Technologies, Inc. | MLO | Class II | |
| K003843 | Envive Miniforms | Procter & Gamble Co. | HHD | Class I | |
| K003666 | Taper-Fit Total Hip System | Corin USA | JDI | Class II | |
| K003641 | Biolok Screw, Biosteon Screw | Biocomposites, Ltd. | HWC | Class II | |
| K003627 | Exel Secure Touch Safety A.v. Fistula Needle Set | Exelint International Co. | FMI | Class II | |
| K003586 | Focus Dailies (Nelfilcon a) One-Day Contact Lenses | Ciba-Geigy Corp. | MVN | Class II | |
| K003535 | Stylet Kit, Models 6254,6282,6293 | Medtronic, Inc. | DRB | Class II | |
| K003512 | Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack II | A.R.C. Laser GmbH | HQC | Class II | |
| K003496 | Cannulated Screw System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HTN | Class II | |
| K002712 | Thermo Tek Ir Forehead Thermometer, Model 718F | Saat, Ltd. | FLL | Class II | |
| K002068 | Org-9200A | Nihon Kohden America Inc | DSI | Class II | |
| K000943 | Cemex System Gun Application Version | Exactech, Inc. | LOD | Class II | |
| K010130 | Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103 | Medtronic Functional Diagnostics A/S | FFX | Class II | |
| K010066 | 5C-Es Cell Control, Models 7547191, 7547192 | Siemens Healthcare Diagnostics Inc. | JPK | Class II | |
| K010064 | 4C-Es Cell, Models 7547187, 7547188, 7547189, 7547190 | Siemens Healthcare Diagnostics Inc. | JPK | Class II | |
| K003757 | Thermofx Mesh | Bionx Implants, Inc. | JEY | Class II | |
| K003604 | Adapters with X-Coating | Terumo Cardiovascular Systems Corporation | DTL | Class II | |
| K003533 | Cross-Checks Lf, Model Ci 119/S &Ci 119/L | Steritec Products, Inc. | JOJ | Class II | |
| K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | DQY | Class II |