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 |
|---|---|---|---|---|---|
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast | EB Neuro S.p.A. | GWF | Class II | |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical Inc | HJK | Class II | |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | DRA | Class II | |
| K151348 | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific LLC | LFG | Class II | |
| K151166 | Instru-Safe Instrument Protection System | Summit Medical, LLC | KCT | Class II | |
| K151140 | LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co.,Ltd. | MAX | Class II | |
| K151009 | Nexus Suture | Baylis Medical Co., Inc. | GAT | Class II | |
| K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | Xtant Medical Holdings, Inc. | MQV | Class II | |
| K150311 | Full Automatic (NIBP)Blood Pressure Monitor | Health & Life Corporation | DXN | Class II | |
| K143729 | SterilContainer S | Aesculap Inc | KCT | Class II | |
| K143289 | Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K151598 | VesselNavigator Rel. 1.0 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K151332 | Nexus Universal, Nexus Universal Chroma | Sybron Dental Specialties, Inc. | EMA | Class II | |
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corp | MML | Class II | |
| K150767 | Edose | Guangzhou Raydose Software Technology., LLC | IYE | Class II | |
| K142995 | Sopix | Sopro - Acteon Group | MUH | Class II | |
| K152044 | Flexor Radial Hydrophilic Introducer Access Set | Cook Incorporated | DYB | Class II | |
| K151372 | Low Dose CT Lung Cancer Screening Option for Qualified GE Systems | GE Healthcare | JAK | Class II | |
| K151309 | Wartie Advanced Wart Remover or other proprietary name | Youmedical B.V. | GEH | Class II | |
| K151172 | MASTERGRAFT Contain | Medtronic Sofamor Danek USA Inc | MQV | Class II | |
| K150857 | Banana Gold | Hankook Latex Gongup Co., Ltd. | HIS | Class II | |
| K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | BZC | Class II | |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Medtronic Xomed, Inc. | ERL | Class II | |
| K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | EBG | Class II | |
| K150169 | Sertera Biopsy Device | Hologic, Inc. | KNW | Class II | |
| K150043 | Transcutaneous Electrical Nerve Stimulators (TENS) | Andon Health Co., Ltd | NUH | Class II | |
| K143613 | PaxWire Occlusion Balloon System | Accessclosure, Inc. | MJN | Class II | |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | Medrad, Inc. | DXT | Class II | |
| K151981 | Turnpike catheter | Vascular Solution, Inc. | DQY | Class II | |
| K151801 | Arc Endocuff Vision | Boddingtons Plastics, Ltd. | FED | Class II | |
| K151702 | Reusable Full Silicone Cover | Laerdal Medical a/S | LIX | Class II | |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific LLC | JXM | Class II | |
| K151533 | Respiratory Gating for Scanners | Varian Medical Systems, Inc. | JAK | Class II | |
| K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems | Zimmer GmbH | LPH | Class II | |
| K151380 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | |
| K151379 | Conventus PRS System | Conventus Orthopaedics, Inc. | HRS | Class II | |
| K151316 | U2 Hip Stem, Ti Porous Coated, Matrix | United Orthopedic Corp. | LPH | Class II | |
| K151277 | Airlock® osteosynthesis plate system | Novastep | HRS | Class II | |
| K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | Ethicon, Inc | GAM | Class II | |
| K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | EBI | Class II | |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | Aesculap Inc | MAX | Class II | |
| K150847 | Foundation Interbody Devices | Corelink, LLC | ODP | Class II | |
| K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) | Kuraray Noritake Dental, Inc. | KLE | Class II | |
| K150695 | Modpod | Hollywog, LLC | ITH | Class II | |
| K150584 | Stryker Suture Tape | Stryker Corp. | GAT | Class II | |
| K150452 | ComboCath OTW PTA Dilatation Catheter | Summa Therapeutics, LLC | LIT | Class II | |
| K143623 | Narval Brux | Resmed SAS | MQC | Unclassified | |
| K143458 | Neurosplint | Neurospectrum, LLC | IQI | Class I | |
| K143446 | Accu-Chek FlexLink Plus infusion set | Roche Diagnostics GmbH | FPA | Class II | |
| K143233 | Mitsar-EEG | Mitsar Co., Ltd. | GWQ | Class II |