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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K152239 | Zero-P Natural Plate System | Synthes (USA) Products LLC | KWQ | Class II | |
| K150787 | Universal Spike | B.Braun Medical, Inc. | LHI | Class II | |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | HLI | Class II | |
| K143711 | Reaxon Plus | Medovent GmbH | JXI | Class II | |
| K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping | Centers for Disease Control and Prevention (CDC) | OZE | Class II | |
| K152943 | NuVasive Foundation-LL System | Nu Vasive, Incorporated | OVD | Class II | |
| K152417 | Adler MicroMed Laser Surgery Fibers | Adler MicroMed, Inc. | GEX | Class II | |
| K152211 | PCT System | Centinel Spine, LLC | NKG | Class II | |
| K152173 | Glidesheath | Terumo Medical Corp. | DYB | Class II | |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | LRC | Class I | |
| K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | FRC | Class II | |
| K151878 | Video Colposcope | Edan Instruments, Inc. | HEX | Class II | |
| K151658 | Gmate Origin Blood Glucose Monitoring System | Philosys, Inc. | NBW | Class II | |
| K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | NHA | Class II | |
| K150640 | RX-FIX Mini Rail External Fixator | Wrightmedicaltechnologyinc | KTT | Class II | |
| K152518 | Vonflex S Putty | Vericom Co., Ltd. | ELW | Class II | |
| K151679 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Heze Yuze Glove Co., Ltd. | LYZ | Class I | |
| K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) | Toshibamedical Systems Corporation | JAK | Class II | |
| K151186 | Stay Fresh Hydrocolloid dressing | Sarasota Medical Products | FRO | Unclassified | |
| K150603 | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube | Teleflexmedical, Inc. | BTR | Class II | |
| K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color | MEDLINE INDUSTRIES, LP - Northfield | KGO | Class I | |
| K153182 | Self- Compressive Screw | Neosteo | HWC | Class II | |
| K153180 | Tyber Medical MST Trauma Screw | Tyber Medical | HWC | Class II | |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | Eastman Kodak Company | MQB | Class II | |
| K153096 | LARIAT RS Suture Delivery Device | Sentreheart, Inc. | GAT | Class II | |
| K152939 | Picasso Plus, Picasso Lite Plus | Amd Group, LLC | GEX | Class II | |
| K152822 | VidiStar HeartView | Vidistar, LLC | LLZ | Class II | |
| K152785 | XIDF-AWS801, Angio Workstation, V6.20 | Toshibamedical Systems Corporation | OWB | Class II | |
| K152779 | Avex CX2 | Opal Orthodontics by Ultradent Products | NJM | Class II | |
| K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) | Varian Medical Systems, Inc. | IYE | Class II | |
| K152573 | 4Sight | Accutome, Inc. | IYO | Class II | |
| K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments | Zimmer GmbH | JWH | Class II | |
| K152490 | DERMABOND PRINEO Skin Closure System | Ethicon, Inc | OMD | Class II | |
| K152000 | SMV Scientific Bone Plate and Screw System | Smv Scientific | HRS | Class II | |
| K151656 | HEARTWAY Power Mobility Scooter | Heartway Medical Products Co., Ltd. | INI | Class II | |
| K151469 | CORVUS Radiation Therapy Planning System | Best Nomos | MUJ | Class II | |
| K150942 | Contour Next USB Blood Glucose Monitoring System | Medrad, Inc. | NBW | Class II | |
| K150561 | NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System | Narang Medical, Ltd. | HRS | Class II | |
| K150528 | Cortisol Saliva Luminescence Immunoassay | Ibl International GmbH | NHG | Class II | |
| K150077 | SonicLift | Pretika Corporation | NFO | Class II | |
| K142211 | Ot Equator | Rhein'83 SRL | NHA | Class II | |
| K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | Inova Diagnostics, Inc. | PIV | Class II | |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | Hardy Diagnostics | JTN | Class II | |
| K152841 | Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws | Zimmer GmbH | HWC | Class II | |
| K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | Hardy Diagnostics | JTN | Class II | |
| K152242 | G3¿ Active Plate® Large Fragment System | Genesis Fracture Care, Inc. | HRS | Class II | |
| K152225 | Edwards eSheath Introducer Set | Edwards Lifesciences LLC | DYB | Class II | |
| K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Co., Inc. | GEI | Class II | |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) | Art Optical Contact Lens, Inc. | LPL | Class II | |
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | Fujirebio Diagnostics, Inc. | OIU | Class II |