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 |
|---|---|---|---|---|---|
| K081106 | Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the Upper Extremity-ASTM F139 | Smith & Nephew, Inc. | HRS | Class II | |
| K081052 | Occlusion Balloon Catheter, Model Venos | Oscor Inc. | DYG | Class II | |
| K080580 | Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small Dds275, Medium Ddm325, Large D | Axelgaard Mfg. Co., Ltd. | EGJ | Class II | |
| K072602 | Vacuette Premium Safety Needle System | Medpro Safety Products, Inc. | FMI | Class II | |
| K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | JAA | Class II | |
| K081439 | Vitoss Bioactive Foam Pack Bone Graft Substitute | DSM Biomedical, Inc. | MQV | Class II | |
| K081414 | Modification to Coral Spinal System | Theken Companies LLC | NKB | Class II | |
| K081324 | Candela Family of Q-Switched Alexandrite Lasers | Candela Corporation | GEX | Class II | |
| K081262 | Dc Neuro | Invivo Corporation | LLZ | Class II | |
| K081057 | Intact Breast Lesion Excision System with Intact Excision Xl | Intact Medical Corporation | KNW | Class II | |
| K080997 | Ascension Pyrocarbon Lunate | Ascension Orthopedics, Inc. | KWN | Class II | |
| K080615 | Endoskeleton Ta Interbody Fusion Device (Ibd) | Titan Spine, LLC | MAX | Class II | |
| K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | JWH | Class II | |
| K080523 | Kronus Blocking Acetylcholine Receptor Autoantibody (Achrab) Ria Assay Kit | Kronus Market Development Associates, Inc. | NST | Class II | |
| K080297 | Medrad Intego Pet Infusion System | Medrad, Inc. | FRN | Class II | |
| K080034 | Three Stage Venous Return Cannula, Model 816460 | Terumo Cardiovascular Systems Corporation | DWF | Class II | |
| K072560 | Envela (Hydrohesive Occlusive Dressing) | Teikoku Pharma USA, Inc. | NAD | Class I | |
| K080023 | Modification to: Spirit | Caire, Inc. | BYJ | Class II | |
| K062254 | Axis Fixation System | Medtronic Sofamor Danek | NKB | Class II | |
| K081589 | Waterlase, Version 3.0 | Biolase MG LLC | GEX | Class II | |
| K081454 | Guarddog Occlusion Guidewire, Inflation Device | Possis Medical, Inc. | MJN | Class II | |
| K081381 | Range Spinal System, Large Denali Screws | K2M, Inc | MNH | Class II | |
| K081212 | Mrsaselect - Extended Incubation | Bio-Rad | JSO | Class II | |
| K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit | Ortho-Clinical Diagnostics, Inc. | LIN | Class II | |
| K080902 | Frems Ssc Disposable Foam Electrodes, Model 800-000-057; Frems Ssc Disposable Non-Woven Electrodes, Model 800-000-058 | Lorenz Biotech S.p.A. | GXY | Class II | |
| K080609 | Swc/dwc Warming Cabinets | Mac Medical | LHC | Class I | |
| K080519 | Prismaflex M150 Set | Gambro Renal Products | KDI | Class II | |
| K080447 | Surgicraft Screw Fixation System | Surgicraft, Ltd. | MBI | Class II | |
| K073598 | Bard Dignicare Stool Management System | C.R. Bard Inc | KNT | Class II | |
| K073416 | Arkray Glucocard 01 Blood Monitoring System | Arkray Factory USA, Inc. | CGA | Class II | |
| K081496 | Optima Pet/ct 560 | GE Healthcare | KPS | Class II | |
| K081469 | Sectra Workstation, Ids7 Version 11.3, Ids5 Version 11.1 P2 | Sectra-Imtec AB | LLZ | Class II | |
| K073288 | Ethicon Endo Surgery Articulating Snare | Ethicon Endo-Surgery Inc | FDI | Class II | |
| K072731 | Endsnor | Dockstader Orthodontic Lab, Inc. | LRK | Class II | |
| K081482 | Csbp-001A Body Organ Perfusion System | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K081427 | Browne Opa Test Strip | STERIS Corporation | JOJ | Class II | |
| K081379 | Modification to Inreach System | Medtronic, Inc. | JAK | Class II | |
| K081304 | Alz Web Pacs, Version 1.0 | Alz, Inc. | LLZ | Class II | |
| K081297 | Vertex Reconstruction System | Medtronic Sofamor Danek | KWP | Class II | |
| K081242 | 21.3 Inch (53Cm) Monochrome Digital Mammography Lcd Monitor Ms51i2, (Mdl2123a) | Tokotu Electric Co., Ltd. | LLZ | Class II | |
| K081091 | Precision 500D r&f X-Ray System | GE Healthcare | JAA | Class II | |
| K080970 | Ushifu Stepper | Ushifu Development Company, LLC | ITX | Class II | |
| K080931 | Vidas C. Dificile Toxin a & B (Cdab) Assay | bioMerieux, Inc. | LLH | Class I | |
| K080888 | Modeification to Iplan Rt Dose | Brainlab, Inc. | MUJ | Class II | |
| K080881 | Cure Catheter Closed System | Cure Medical, LLC | KOD | Class II | |
| K080834 | Vintage Art | Shofu Dental Corp. | EIH | Class II | |
| K080724 | Gc Opb-100 | GC America Inc. | DYH | Class II | |
| K080589 | Saturn 9000-810 | New Medical Co., Ltd. | MQB | Class II | |
| K080585 | Desktop Pro | Elekta Limited | IYE | Class II | |
| K080517 | Resicem | Shofu Dental Corp. | EMA | Class II |