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 |
|---|---|---|---|---|---|
| K002823 | Renu Multiplus Multi-Purpose Disinfecting Solution | Bausch & Lomb Incorporated | LPN | Class II | |
| K002482 | Vision 9000 Phased Array Torso Coil | GE Healthcare Coils | MOS | Class II | |
| K002420 | Hitachi Altaire | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K002408 | Axion Plus (Methafilcon a) Soft (Hydrophilic) Aspheric Contract Lens | Unilens Corp., USA | LPL | Class II | |
| K002198 | Fluoroscan Profile, Model Tca 4 Plus; Fluoroscan Profile Iq, Model Tca 4R Plus | Fluoro Scan Imaging Systems, Inc. | OWB | Class II | |
| K000929 | Prolite Pulsed Light System | Medical Bio Care Sweden AB | GEX | Class II | |
| K000252 | Insight 4000 Endoscope | Insight Instruments Mfg., Inc. | MPA | Class II | |
| K002959 | Modification to Isobar Spinal System | Encore Orthopedics, Inc. | KWP | Class II | |
| K002922 | Omni Grace Latex Examination Glove, Powdered, with Protein Claim (200 Micrograms or Less) | Omnigrace (Thailand), Ltd. | LYY | Class I | |
| K002870 | Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color | Shanghai PT Plastics Enterprise Company, Ltd. | LYZ | Class I | |
| K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07 | Hdc Corp. | CAZ | Class II | |
| K980974 | Safe Mini | Polystan A/S | DTZ | Class II | |
| K003057 | Autostat II Ena-4 Profile Elisa | Cogent Diagnotics, Ltd. | LLL | Class II | |
| K003054 | Autostat II Ena-6 Profile Elisa | Cogent Diagnotics, Ltd. | LLL | Class II | |
| K003022 | Aeroneb Portable Nebulizer | Aerogen Ltd. | CAF | Class II | |
| K002909 | Acryderm Silver Antimicrobial Strands Model a-020103 | Acrymed, Inc. | FRO | Unclassified | |
| K002883 | Pinnacle Metal-on-Metal Acetabular Cup Liners | Depuy Orthopaedics Inc. | KWA | Class III | |
| K002882 | Hl168b | Health & Life Corporation | DXN | Class II | |
| K002871 | Modification to Yasargil Aneurysm Clips | Aesculap Inc | HCH | Class II | |
| K002858 | Xia Spine System | Howmedica Osteonics Corp | KWQ | Class II | |
| K002651 | C-Reactive Protein (High Sensitivity) Reagent Set | Horiba Instruments Incorporated | DCK | Class II | |
| K002562 | Pacifier Thermometer Models Vt-901F, Vt901c | Valeo Corp. | FLL | Class II | |
| K002467 | Coaliza Protein S-Free | Instrumentation Laboratory Co. | GGP | Class II | |
| K002396 | Endocare Percutaneous Access Set | Varian Medical Systems, Inc. | KOD | Class II | |
| K002233 | Bvi Sling | Bio-Vascular, Inc. | PAJ | Class II | |
| K002180 | Simplicity Disposable Pen Needle | Sterling Medivations, Inc. | FMI | Class II | |
| K002168 | Aspiject Self-Aspirating Dental Injection Syringe | Ronvig Instruments, Ltd. | EJI | Class II | |
| K002147 | Focus | Elekta Limited | MUJ | Class II | |
| K001578 | Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter | Boston Scientific Corporation | DQO | Class II | |
| K000666 | Tc-Plus Solution Knee | Plus Orthopedics | JWH | Class II | |
| K003014 | Somatom Emotion Ms | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K002867 | Inverness Medical Ovulation Predictor Test | Selfcare, Inc. | CEP | Class I | |
| K002855 | Biolyte 2000 Na+,k+,cl-/Li+electrolyte Analyzer | Biocare Corp. | JGS | Class II | |
| K002745 | Vinyl Examination Gloves, Powder Free, Blue Color | Arista Latindo Industrial, Ltd. P.T. | LYZ | Class I | |
| K002737 | Smith & Nephew Porps & Torps | Gyrus Ent LLC | ETB | Class II | |
| K002191 | Carriazo Barraquer II Microkeratome | Moria SA | HMY | Class I | |
| K002143 | Dynalink Biliary Self-Expanding Stent System | Boston Scientific Corporation | FGE | Class II | |
| K002133 | Nir Billiary Stent System; Marshal Balloon Dilatation Catheter | Boston Scientific Corporation | FGE | Class II | |
| K002983 | C.t.m. Power Chair, Model Hs-5600 | Warepalmy Enterprise, LLC (USA) | ITI | Class II | |
| K002974 | Emit Tox Acetaminophen Assay, Model 7A319ul; Emit Tox Ecetaminophen Calibrators, Model 7A409ul | Siemens Healthcare Diagnostics Inc. | LDP | Class II | |
| K002897 | Titanium Middle Ear Prostheses | Xomed, Inc. | ETB | Class II | |
| K002881 | Ventilator, Continuous (Respirator), Model Ltv 1000 | Pulmonetic Systems, Inc. | CBK | Class II | |
| K002876 | Jobsite Enhanced Mobility Chair, Model Jem | Suiter Medical LLC | IOR | Class I | |
| K002746 | Vinyl Examination Gloves, Powder Free, Vanilla Color | Arista Latindo Industrial, Ltd. P.T. | LYZ | Class I | |
| K002690 | Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 | Nonin Medical, Inc | DQA | Class II | |
| K002684 | Composix E/x Mesh | C.R. Bard Inc | FTL | Class II | |
| K002673 | Ez-Comfort Transporter 2000 Series | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I | |
| K002671 | Ez-Traveler 2500 Series Manual Wheelchair | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I | |
| K002670 | Ez-Traveler 3000 Series Manual Wheelchair | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I | |
| K002669 | Ez-Light 4000 Series Manual Wheelchair | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I |