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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180329 | ClotTriever Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K180208 | Disposable Endoscopic Trocar | Fengh Medical Co., Ltd. | GCJ | Class II | |
| K180083 | Silicone Personal Lubricant, ALL-IN-ONE | United Consortium | NUC | Class II | |
| K173889 | Medline Cautery Electrode (PTFE) | MEDLINE INDUSTRIES, LP - Northfield | GEI | Class II | |
| K173386 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs | Lucenxia Prescience AG | KGO | Class I | |
| K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | HGH | Class II | |
| K171409 | Ot Equator | Rhein'83 SRL | NHA | Class II | |
| K180630 | PTFE Surgical Suture | Omnia SRL | NBY | Class II | |
| K180614 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Ltd | OMP | Class II | |
| K180584 | Viveve RF System, Secure | Viveve, Inc. | GEI | Class II | |
| K180324 | Patriot Spinal Fixation System | Valorus Spine, LLC | NKB | Class II | |
| K180271 | NAVIO™ Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | OLO | Class II | |
| K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | |
| K180033 | 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. | NAY | Class II | |
| K173775 | Clench Compression Staple | F & A Foundation, LLC D.B.A. Reign Medical | JDR | Class II | |
| K173767 | A. L. P. S. Clavicle Plating System | Zimmer GmbH | HRS | Class II | |
| K173525 | NovoGro | Osteonovus, Inc. | MQV | Class II | |
| K172956 | Medicant Mucosal Atomizer | Medica Holdings, LLC | CCT | Class II | |
| K172173 | DiaSpect Tm, DiaSpect Tm Cuvettes | Ekf Diagnostic GmbH | GKR | Class II | |
| K170570 | Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung | Varian Medical Systems, Inc. | IYE | Class II | |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics Corp. | MCW | Class II | |
| K180589 | DR 800 with MUSICA Dynamic | AGFA Healthcare Corp. | JAA | Class II | |
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed | HKI | Class II | |
| K180376 | K2M Patient Specific Rods | K2M, Inc | NKB | Class II | |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co., Ltd. | NFT | Class II | |
| K180344 | TheraCal DC | Bisco Inc | EJK | Class II | |
| K180125 | PowerLook Density Assessment Software | iCAD, Inc. | LLZ | Class II | |
| K180089 | Medacta Shoulder System Short Humeral Diaphysis | Medacta International SA | PHX | Class II | |
| K173897 | syngo.via MI Workflows | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K173867 | Axis Anterior Cervical Plate System | Axis Orthopaedics | KWQ | Class II | |
| K173586 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences LLC | KRA | Class II | |
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | PDQ | Class II | |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | OXF | Class II | |
| K173207 | SIC invent Dental Implant Systems | Sic Invent AG | DZE | Class II | |
| K172998 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K172368 | Bipolar Micro-Coagulation Forceps | Gunter Bissinger Medizintechnik GmbH | GEI | Class II | |
| K172156 | PENTAX Medical EPK-3000 Video Imaging System | PENTAX of America, Inc. | EOB | Class II | |
| K172014 | Wedge Microcatheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K171847 | Corin Optimized Positioning System (OPS™) Plan | Corin USA | LLZ | Class II | |
| K171713 | Neodent Instrument Kits | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | EBD | Class II | |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | HIR | Class II | |
| K180595 | SciMoCa | Radialogica LLC | IYE | Class II | |
| K180571 | GammaPod | Xcision Medical Systems, LLC | IWB | Class II | |
| K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | EHD | Class II | |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations | MED | Class II | |
| K180339 | Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K180088 | TrapLiner catheter | Vascular Solutions LLC | DQY | Class II | |
| K173699 | The Pump by Babyation | Babyation Inc. | HGX | Class II | |
| K173597 | Scenium VE20 Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II |