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 |
|---|---|---|---|---|---|
| K002753 | Spartan a-10 | Spartan Ultrasonics, Inc. | ELC | Class II | |
| K002749 | Endoscope Contour Detection Device, Model 3Dx45 and Colonoscope, Model Xcf-Q140l/13d | Olympus Optical Co., Ltd. | FDF | Class II | |
| K002391 | Nitrile Patient Examination Glove, Powdered, Non-Sterile, (Multiple Colors) | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K002224 | Xps 3000 System | Medtronic Xomed, Inc. | ERL | Class II | |
| K001211 | Modification to Intralase 600C Laser Keratome | Intra Lase Corp. | GEX | Class II | |
| K000846 | Tkd Scalers | Orasystems | ELC | Class II | |
| K003534 | Pentra 5D | R & D Systems, Inc. | JPK | Class II | |
| K003445 | Fresenius Viral Blocking Transducer Protector for Hemodialysis, Model 04-9500-2 | Fresenius Medical Care Renal Therapies Group, LLC | FIB | Class II | |
| K003421 | Depuy C-Stem System | Depuy Orthopaedics Inc. | JDI | Class II | |
| K003398 | Wireclip Torquer | Boston Scientific Corporation Northwest Technology | DQX | Class II | |
| K003276 | Tyshak Mini Pediatric Ptv Catheter, Model 107 | Numed Inc | LIT | Class II | |
| K003266 | Siremobil ISO-C 3D | Siemens Medical Solutions USA, Inc. | OXO | Class II | |
| K003110 | Medcomp Bio-Cath Catheter Line | Medcomp | LJS | Class II | |
| K002807 | 3D Organ Assessment W/ Magnetic Position Sensing | Acuson Corp. | IYO | Class II | |
| K003497 | Disposable Pressure Monitor | Engineered Medical Systems, LLC | CAP | Class II | |
| K003429 | Malloy/head Lateralized Press-Fit Femoral | Zimmer GmbH | LPH | Class II | |
| K003379 | V-40/C-Taper Adapter Sleeve | Howmedica Osteonics Corp | LZO | Class II | |
| K003242 | Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623 | Bio-Rad | JJS | Class I | |
| K003239 | Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), Model504,505,506 | Bio-Rad | JJS | Class I | |
| K003096 | Fastpack Calibrators | Qualigen Inc | JIT | Class II | |
| K003034 | Coltene Aura Compomer Restorative System | Coltene /Whaledent AG | EBF | Class II | |
| K002766 | Nicolet Vasoguard | Nicolet Biomedical, Inc. | JOP | Class II | |
| K002740 | Tibial & Patellar Components for the Profix & Genesis II Total Knee Systems | Smith & Nephew, Inc. | JWH | Class II | |
| K002493 | Dideco Micro 40 Ph.i.s.i.o (Phosphorylcholine Insert Surface in Oxgenation) Newborn/infant Arterial Filter | LivaNova USA, Inc. | DTM | Class II | |
| K001510 | Os-2000 Optical Sonography System | Advanced Diagnostics, Inc. | NCS | Class II | |
| K000806 | Karl Storz Hysteromat II | Karl Storz Endoscopy-America, Inc. | HIG | Class II | |
| K993852 | First Check Home Drug Test Panel 4 | Worldwide Medical Corp. | LAF | Class II | |
| K003213 | Almatex Powder-Free Latex Exanination Gloves with Protien Labeling Claim 50 Micrograms or Less | Concept Rubber Products Sdn Bhd | LYY | Class I | |
| K003095 | Fastpack Control | Qualigen Inc | JJX | Class I | |
| K003030 | Lyphochek Hemoglobin Alc Linearity Set | Bio-Rad | GGM | Class II | |
| K002986 | A.r.c. Low Bubble Turbo Needle, Model We0106.5 | A.R.C. Laser GmbH | HQC | Class II | |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16 | BD Becton Dickinson Vacutainer Systems Preanalytic | FMI | Class II | |
| K002861 | Eo Gas Sterilization Process Indicator Tapes, Model Ci 124 | Steritec Products, Inc. | JOJ | Class II | |
| K002834 | Srs Vaginal Emg/stimulation Perineometer Sensor Srs Anal Emg/stimulation Perineometer Sensor | Srs Medical Systems, Inc. | HIR | Class II | |
| K002819 | Nitrile Patient Examination Glove (Green Color) Powdered, Non Sterile | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K002818 | Nirtrile Patient Examination Glove (Blue Color) Powdered, Non Sterile | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K002787 | Model 120, Oxysoft, Infrared Data Converter, Model 120 | Palco Labs, Inc. | DQA | Class II | |
| K002781 | Medical Cables Patient Monitoring Cables for ECG, EEG, Spo2, and Blood Pressure Monitors | Medical Cables, Inc. | DSA | Class II | |
| K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | FTL | Class II | |
| K002593 | Powder Free Sterile Latex Surgical Gloves, Contains 50 Microgram or Less of Total Water Extractable Protein per Gram | Hartalega Sdn Bhd | KGO | Class I | |
| K002472 | Delta 32 and Delta 32 Tact | Instrumentarium Imaging, Inc. | IZH | Class II | |
| K002010 | Stc Methadone Intercept Micro-Plate Eia, Model 11421 | OraSure Technologies, Inc. | DJR | Class II | |
| K001525 | Captia Syphilis-G Elisa Test System | Trinity Biotech, PLC | LIP | Class II | |
| K001278 | Sensaire Diagnostic Spirometer | VectraCor, Inc. | BZG | Class II | |
| K000004 | Alliance Left Heart Delivery System Introducer, Model #407509 | Daig Corp. | DYB | Class II | |
| K003473 | Digimam Digital Stereotactic Biopsy System Option for Glory Mammographic System | Elscintec Systems, Ltd. | IZH | Class II | |
| K003391 | Osteonics Alumina C-Taper Head | Howmedica Osteonics Corp | LZO | Class II | |
| K003373 | Procad Add-on | Ivoclar North America, Inc. | EIH | Class II | |
| K003361 | Renew Ls-2 | Bisco Inc | EBF | Class II | |
| K003011 | Self Etch Bonding Primer | Jeneric/Pentron, Inc. | KLE | Class II |