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 |
|---|---|---|---|---|---|
| K000931 | Au5 Ultrasound Imaging System | Esaote North America, Inc | IYN | Class II | |
| K000904 | Penadapt 10 | Buffalo Filter Co., Inc. | FYD | Class II | |
| K000842 | Cadd-Prizm Pcs II Model 6101 Ambulatory Infusion System | Sims Deltec, Inc. | FRN | Class II | |
| K000836 | Biosorbpdx Bioabsorbable Fixation System | Bionx Implants, Inc. | JEY | Class II | |
| K000817 | Omega II Modular Total Hip System | Osteoimplant Technology, Inc. | JDI | Class II | |
| K000815 | As/3 Anesthesia Montior with S-Ane99(a)/l-Ark99(a) | GE Healthcare | MHX | Class II | |
| K000813 | Flexam Nitrile T Ambi Examination Gloves with Chemo Claim | Allegiance Healthcare Coporation | LZA | Class I | |
| K000798 | Talon Balloon Dilation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K000792 | Citrasate Dialysate Acid Concentrate Liquid, Models Cs-1Xxx-Xx, Cs-Xxx-Xx, Cs-3Xxx-Xx | Advanced Renal Technologies, Inc. | KPO | Class II | |
| K000747 | Univec Two Piece Syringe | Univec, Inc. | FMF | Class II | |
| K993066 | Window Cervical Dynamic Plate System | Advanced Spine Technology, Inc. | KWQ | Class II | |
| K992932 | Cipa (Adults) Cipi (Infants) | DMC Medical Ltd. | DWF | Class II | |
| K992799 | Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit | Sangui Biotech, Inc. | GGT | Class II | |
| K992221 | Acticoat Primary Antimicrobial Dressing | Westaim Biomedical, Inc. | FRO | Unclassified | |
| K984376 | Endor 2000 | T.C. Medical, Inc. | GZJ | Class II | |
| K001548 | Modular Rotating Hinge Knee Crossover Tibial Bearing Components | Howmedica Osteonics Corp | KRO | Class II | |
| K001487 | Hardydisk Cinoxacin, 100 Mcg | Hardy Diagnostics | JTN | Class II | |
| K001454 | Silverspeed Hydrophilic Guidewire (0.014 Diameter, 145Cm Length, Support) Silverspeed Hydrophilic Guidewire (0.014 D | Medtronic, Inc. | DQX | Class II | |
| K001437 | Ensite 3000 System, Model Ee3000 | Endocardial Solutions, Inc. | DQK | Class II | |
| K001436 | Agilent M2636a Telemon Monitor | Agilent Technologies, Inc. | DSI | Class II | |
| K001393 | The Aptus, Automated Application of the Gliadin Iga Elisa Test System. an Enzyme Linked Immunosorbent Assay, Elisa for | Zeus Scientific LLC | MST | Class II | |
| K001192 | Self Adhering Navigus Guide | Image-Guided Neurologics, Inc. | HAW | Class II | |
| K001161 | Ultrapen Reusable Pencil, Model 130350 Through 130353, Reusable Accessory Electrode Kit (for Use with Ultrapen Pencil), | Conmedcorp | GEI | Class II | |
| K001159 | Hyfrecator 2000 Reusable Hand-Switching Accessory Handpiece/foot-Switching Accessory Handpiece, Hyfrecator Plus Reusabl | Conmedcorp | GEI | Class II | |
| K000702 | Borla Transducer Protector & Haemotronic Transducer Protector | Fresenius Medical Care Renal Therapies Group, LLC | FIB | Class II | |
| K000535 | Quanta Lite Lkm-1 Elisa | Inova Diagnostics, Inc. | NBS | Class II | |
| K000492 | Mda D-Dimer | bioMerieux, Inc. | DAP | Class II | |
| K992835 | C.s.o. Tonometer | Cso | HKY | Class II | |
| K992404 | The Wand | Spintech, Inc. | FMF | Class II | |
| K991206 | Bonasse Contact Lens Case | Bonasse Ent. Co., Ltd. | LRX | Class II | |
| K001036 | Sensititre 18-24 Hours Susceptibility Plates (Moxifloxacin) | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20 | Richard Wolf Medical Instruments Corp. | FGA | Class II | |
| K993874 | Bofor Revision Coup | Plus Orthopedics | LZO | Class II | |
| K993772 | X-Coated Capiox Sx18 and Sx25 Hollow Fiber Oxygenator with/ without Detachable Hardshell Reservoir | Terumo Medical Corp. | DTZ | Class II | |
| K990435 | Bestneb Portable Aerosol Therapy Unit, Ap-100100 | Apex Medical, Inc. | CAF | Class II | |
| K001597 | Conmed Trogard Finesse Trocar System, Model 60-6050-Xxx | Conmedcorp | GCJ | Class II | |
| K000998 | Option Care System for the Cleaning and Disinfecting of Soft (Hydrophilic) Contact Lenses | Optisonic, Inc. | LPN | Class II | |
| K000882 | Datex-Ohmeda Cs/3 Telemetry System | GE Healthcare | MHX | Class II | |
| K000831 | Stat-Shell Disposable Sp02 Sensor | Epic Medical Equipment Services, Inc. | DQA | Class II | |
| K000820 | Avanar F/x 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700 | Endosonics Corp. | DQO | Class II | |
| K000767 | Memcath Urology Introducer Sheath, Model 201 | Memcath Technologies, LLC | KNY | Class II | |
| K000744 | Medtronic Ave Bridge X3 Stent | Medtronic, Inc. | FGE | Class II | |
| K000001 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System | Boston Scientific Corporation | JCT | Class II | |
| K001627 | Trifix Spinal Fixation System | Endius, Inc. | MNH | Class II | |
| K001148 | Merogel Otologic Pack | Xomed, Inc. | KHJ | Class II | |
| K994405 | Instant-View Marijuana Urine Cassette Test | Alfa Scientific Designs, Inc. | DKE | Class II | |
| K994106 | Olympus Um-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use | OLYMPUS Corporation of the Americas | ITX | Class II | |
| K994069 | Olympus Um-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use | OLYMPUS Corporation of the Americas | ITX | Class II | |
| K993895 | Optirad | Optivus Proton Therapy, Inc. | MUJ | Class II | |
| K993700 | Pharmaseed, Model Bt-103-2 | Syncor International, Inc. | KXK | Class II |