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 |
|---|---|---|---|---|---|
| K013596 | Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap) | Accumetrics, Inc. | JOZ | Class II | |
| K011726 | Millenium's Skelite Synthetic Resorbable Bone Void Filler | Millenium Biologix, Inc. | MQV | Class II | |
| K021422 | Philips Information Center Software Revision D.02 | Philips North America LLC | MHX | Class II | |
| K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 | Medela AG | BTA | Class II | |
| K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | OTN | Class II | |
| K021249 | Surgassist Flexshaft 2, Model Fs2 14 | Power Medical Interventions, Inc. | GDW | Class II | |
| K021228 | Hi-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the Balance Middleweight Universal Guide | Boston Scientific Corporation | DQX | Class II | |
| K021215 | Bio-Logic Abaer Cub | Bio-Logic Systems Corp. | GWJ | Class II | |
| K021175 | Aeroneb Professional Nebulizer System, Model#ag-Ap6000 | Aerogen Ltd. | CAF | Class II | |
| K021132 | Uni-Patch Ultrasound Coupling Gel | The Ludlow Company LP | MUI | Class II | |
| K021107 | Fortaflex Surgical Sling | Organogenesis, Inc. | FTM | Class II | |
| K021042 | Thermo Forma, Cryomed, Controlled Rate Freezers; Models # 7456, 7457, 7458,7459,7475,7476 | Thermo Forma, Inc. | MQG | Class II | |
| K020859 | Cefotaxime | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K020842 | Ertapenem 10Ug Bbl Sensi-Disc | Becton Dickinson & Co | JTN | Class II | |
| K020840 | Vital Scientific Pt with Calcium | VitalScientific | GJS | Class II | |
| K020771 | Acon One Step Drug Screen Test Card | Acon Laboratories, Inc. | DIO | Class II | |
| K020726 | Dukal Disposable Vaginal Speculum, Small, Medium, and Large | Dukal Corp. | HIB | Class II | |
| K020652 | Herniamesh T-Sling | Herniamesh SRL | PAH | Class II | |
| K020633 | Natural and Colored Latex Condom with Flavors | Ls Rubber Sdn Bhd | HIS | Class II | |
| K020538 | Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 Series | Boehringer Laboratories, LLC | DWL | Class II | |
| K021350 | Abbott Plum A+3 Multichannel Infusion Pump, Model 12348 | Abbott Medical | FRN | Class II | |
| K021308 | Glovco Powder-Free Nitrile Examination Gloves | Glovco (M) Sdn. Bhd. | LZA | Class I | |
| K021296 | Simplicity Qd Easy P Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K021178 | Sl-Plus Lateralized Stem | Plus Orthopedics | JDI | Class II | |
| K021059 | Syntex Powder-Free Latex Examination Gloves with Low Protein Claim | Syntex Healthcare Products Co., Ltd. | LYY | Class I | |
| K021058 | Syntex Powder-Free Multi-Ply Latex Examination Gloves with Low Protein Claim | Syntex Healthcare Products Co., Ltd. | LYY | Class I | |
| K021023 | Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed) | Instrumentation Laboratory Co. | GGN | Class II | |
| K021022 | Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed) | Instrumentation Laboratory Co. | GGN | Class II | |
| K020823 | Peliclass Human Igg Subclass Nephelometric Immage Kit | Sanquin Blood Supply Foundation | DFZ | Class II | |
| K020816 | Iron-Pc-Sl Assay Model # 151-10, 151-26 | Sekisui Diagnostics P.E.I. Inc. | JIY | Class I | |
| K020713 | Ms-30 Lateral Femoral Stem | Sulzer Orthopedics, Inc. | LZO | Class II | |
| K020664 | Sterisharp 3-Gallon Rsdc, Model Rsdc3g | Sterilogic Waste Systems, Inc. | MMK | Class II | |
| K020618 | Aalto Scientific Mirco Hematocrit Control | Aalto Scientific Ltd. | GLK | Class II | |
| K020489 | G7 Automated Hplc Analyzer, Beta-Thalassemia Mode | Tosoh Medics, Inc. | JPD | Class II | |
| K020355 | I-Stat Prothrombin Time Test | I-Stat Corp. | GJS | Class II | |
| K014278 | Latex Surgeons Glove (Powdered) | Brightway Gloves Pvt., Ltd. | KGO | Class I | |
| K013840 | Microjet Crono Par and Crono Apo-Go | Cane S.r.l. | FRN | Class II | |
| K013787 | Nycocard Crp | Trinity Biotech (Primus Corporation dba Trinity Biotech) | DCK | Class II | |
| K013587 | Babies Best Water Teether / Gum Soother, Various | Babies Best, Inc. | KKO | Class II | |
| K012658 | Reprocessed Compression Limb Sleeves | Surgical Instruments Service and Savings, Inc. | JOW | Class II | |
| K021416 | Aquasil Ultra Monophase/heavy/lv Smart Wetting Impression Material | Dentsply Intl. | ELW | Class II | |
| K021395 | Modification to 30 Extension Set | Vygon Mfg | FPA | Class II | |
| K021246 | Sensaid, Models# Rc-Nva30-10; Rc-Cs140-10; Rc-Bc150-3 | Sensidyne, Inc. | DQA | Class II | |
| K021226 | Modification to Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek | KWQ | Class II | |
| K021182 | Radiolucent Colles Compression/distraction Bar | Zimmer GmbH | JDW | Class II | |
| K021126 | Everstick Ortho | Stick Tech Ltd. | EBI | Class II | |
| K020615 | Super Secur-Fit Ha Hip Stems and Super Secur-Fit Plus Ha Hip Stems | Howmedica Osteonics Corp | MEH | Class II | |
| K020579 | Aaron Arthroscopy Electrode, Catalog Numbers Ar00, Ar01, Ar02, and Ar03 | Apyx Medical Corporation | GEI | Class II | |
| K021413 | Aquasil Ultra Rigid Smart Wetting Impression Material | Dentsply Intl. | ELW | Class II | |
| K021258 | Germ Terminator Gt 100 Toothbrush Sanitizer | Germ Terminator Corporation | MCF | Class I |