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 |
|---|---|---|---|---|---|
| K071920 | Autosuture Absorbable Tack and Applicator | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K071845 | Relieva Luma Sinus Illumination System, Model Sis-100A | Acclarent Inc | KAM | Class I | |
| K071830 | Depuy Delta Ts Ceramic Femoral Heads | Depuy Orthopaedics Inc. | LZO | Class II | |
| K071727 | Qxt Extraction Catheter | Vascular Solutions LLC | QEZ | Class II | |
| K071533 | Fitmate Series | Cosmed S.r.l. | BZL | Class II | |
| K071250 | Ca, Model: Cam | Optovue Inc. | OBO | Class II | |
| K071056 | Neutrophase Wound Cleanser | Novabay Pharmaceuticals, Inc | FRO | Unclassified | |
| K070822 | Architect Sirolimus Assay | Fujirebio Diagnostics, Inc. | NRP | Class II | |
| K061519 | Modification to Dbb-05 Hemodialysis Delivery System | Nikkiso Co., Ltd. | KDI | Class II | |
| K072493 | Enseal Tissue Sealing Device | Surgrx, Inc. | GEI | Class II | |
| K072413 | Modification to: Jazz Blood Glucose Monitoring System | Agamatrix | NBW | Class II | |
| K072095 | Synthes (USA) Pediatric Lcp Hip Plate System Modifications | Synthes (USA) Products LLC | JDS | Class II | |
| K071800 | Philips Avalon Fetal Monitors Fm20 and Fm30 | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | HGM | Class II | |
| K071762 | Omniwave Endovascular System | Omnisonics Medical Technologies | QEY | Class II | |
| K071708 | I45, I45s, I60, and I60s | Power Medical Interventions, Inc. | GDW | Class II | |
| K071578 | Bloodstop and Bloodstop IX Hemostatic Gauze, Models Bs-10,Bs-11,Bs-12,B-13, Bs-Ix27, Bs-IX-14, Bsix-15, Bsix-17 | Lifescience Plus, Inc. | QSY | Unclassified | |
| K063838 | Lipoprotein(a), Lipoprotein(a) Calibrator, Lipoprotein (a) Control, Control High | Thermo Electron Oy | DFC | Class II | |
| K063637 | Reliance Vbs System | Reliance Medical Systems, LLC | MQP | Class II | |
| K072517 | Ilab Ultrasound Imaging System, Version 1.3 | Boston Scientific Corporation | IYO | Class II | |
| K072497 | P.004 Nc Gold Abutment for Crowns | Straumann USA, LLC | NHA | Class II | |
| K072431 | Asahi Ptca Guide Wire, X-Treme | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K072355 | Ossifuse Bone Substitute Material | Etex Corp. | MQV | Class II | |
| K072296 | Poiint of Care Stranding System, Mode 1004-00 | Theragenics Corp. | KXK | Class II | |
| K071998 | Arrow Echogenic Introducer Needle Component | Arrow Intl., Inc. | FMI | Class II | |
| K071964 | Mim 4.1 (Seastar) | MIM Software Inc | LLZ | Class II | |
| K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) | Cordis Neurovascular, Inc. | HCG | Class II | |
| K071919 | P.004 Abutments | Straumann USA (on Behalf of Institut Straumann AG) | NHA | Class II | |
| K071357 | P.004 Nc Anatomic Abutments | Straumann USA, LLC | NHA | Class II | |
| K070881 | Lem Hemorrhoidal Ligator, Models A.5650, A.5660 | Sapimed S.p.A. | FHN | Class II | |
| K070339 | Disposable Temperature Probes/sensors and Instrument Cables | Gentherm Medical, LLC | FLL | Class II | |
| K070156 | Bioz Dx Hemodynamic Monitor with Philips 12-Lead ECG, Model 5100 | Cardiodynamics International Corp. | DSB | Class II | |
| K072542 | Maxplus Tru-Swab Positive Displacement Connector | Medegen Medical Manufacturing System | FPA | Class II | |
| K072541 | Senosonix Ultrasound Breast Biopsy System | Senorx, Inc. | ITX | Class II | |
| K072392 | Opdima Digital Mammographic X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | Class II | |
| K072203 | Harmonic 10Cm Combination Hook Blade | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K071970 | Clear Image Aligner | Specialty Appliances, LLC | NXC | Class II | |
| K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-Xx | Datascope Corp. | DSI | Class II | |
| K071744 | Aviafit Pulsating Legband | Flowmedic, Ltd. | JOW | Class II | |
| K071457 | Modification to Radius Snare | Radius Medical Technologies, Inc. | MMX | Class II | |
| K070556 | Brainsuite Net | Brainlab, Inc. | HAW | Class II | |
| K072443 | Vitros Chemistry Products Ca Dt Slides and Dt Calibrator Kit and Vitros Ca Assay | Ortho-Clinical Diagnostics, Inc. | CJY | Class II | |
| K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer System | Migada Plant | LHI | Class II | |
| K071732 | Marrowminer | Stemcor Systems, Inc. | GDM | Class I | |
| K071510 | Herpeselect Express Igg, Herpeselect Express Controls, Models Rt0920g, Rt0950 | DiaSorin Molecular LLC | MXJ | Class II | |
| K071346 | Immulisa Intrinsic Factor Antibody Elisa | Immco Diagnostics, Inc. | LIG | Class II | |
| K070809 | Bd Phoenix Automated Microbiology System-Minocycline (Gp) 1-32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K070432 | General Surgery Drapes | Welmed, Inc. | KKX | Class II | |
| K063675 | Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation Kit | Ortho-Clinical Diagnostics, Inc. | LJP | Class I | |
| K072514 | Visulas Trion | Carl Zeiss Meditec Inc | GEX | Class II | |
| K072504 | Cyberknife Robotic Radiosurgery System | Accuray Incorporated | IYE | Class II |