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 |
|---|---|---|---|---|---|
| K072060 | Qp-156E ECG Exercise Test Option for the ECG-1500A Series/cardiofax V | Nihon Kohden America Inc | DPS | Class II | |
| K071985 | Ge Vivid S5 and S6 Diagnostic Ultrasound | General Electric Co. | IYN | Class II | |
| K071834 | Stratus Cs Acute Care Nt-Probnp Testpak, Model Cpbnpm | Siemens Healthcare Diagnostics Inc. | NBC | Class II | |
| K071790 | Genesis II Total Knee System, Legion Revision Knee System, Journey Bcs Knee System | Smith & Nephew, Inc. | MBH | Class II | |
| K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip | Integra Radionics, Inc. | LFL | Unclassified | |
| K071586 | Bioraptor 2.3 Pk Suture Anchor | Smith & Nephew, Inc. | MBI | Class II | |
| K071518 | Diacap Lo Ps (10, 12, 15) and Diacap Hi Ps (10, 12, 15, 18, 20) Hemodialyzers | B. Braun Medizintechnologie GmbH | KDI | Class II | |
| K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | MQC | Unclassified | |
| K071320 | Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 | Everlife Medical Equipment Co., Ltd. | IPF | Class II | |
| K071190 | Root Zx II | J. Morita USA, Inc. | EKX | Class I | |
| K070970 | Neuron Support Catheter System, Model 5F/6f | Penumbra Inc. | DQY | Class II | |
| K070267 | Depuy Gck Tibial Components | Depuy Orthopaedics Inc. | HRY | Class II | |
| K070036 | Reprocessed Medtronic Cardiac Stabilization and Positioning Devices | Stryker Sustainability Solutions | NQG | Class I | |
| K070034 | Reprocessed Guidant Cardiac Stabilization and Positioning Devices | Stryker Sustainability Solutions | NQG | Class I | |
| K070002 | Boston Scientific Peripherally Inserted Central Catheter | Boston Scientific Corporation | LJS | Class II | |
| K071894 | Xebra Dicom Image Browser | Hx Technologies, Inc. | LLZ | Class II | |
| K071459 | B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes | B.Braun Medical, Inc. | FMF | Class II | |
| K071308 | Modification to Neuviz Dual Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | JAK | Class II | |
| K071126 | Cryoseal Fs Applicator System | ThermoGenesis Corp. | FMF | Class II | |
| K070135 | Vitrifreeze Medium; Vitrithaw Medium | Fertipro N.V. | MQL | Class II | |
| K070020 | Comcaset-P Safety IV Catheter | Pitango Medical, Ltd. | FOZ | Class II | |
| K063836 | Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701 and 41704-41715 | Medtronic Neurosurgery | JXG | Class II | |
| K063671 | Rebound Hrd | Minnesota Medical Development, Inc. | FTL | Class II | |
| K063447 | Insight Discovery | Fasstech | IKN | Class II | |
| K060980 | Vendys Model 5000 B/bc | Endothelix, Inc. | DQK | Class II | |
| K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective Caps | Straumann USA, LLC | NHA | Class II | |
| K072001 | Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | |
| K071992 | High-Definition 120 Multileaf Collimator (Hd120 Mlc) | Varian Medical Systems, Inc. | IYE | Class II | |
| K071991 | Modification to Scorpio Nrg Knee System | Howmedica Osteonics Corp | JWH | Class II | |
| K071978 | Mini Tightrope Ft Repair Kit | Arthrex GmbH | HTN | Class II | |
| K071756 | Endohub- 1.0 Endoscopic Video Camera System with Video Capture | Pointe Conception Medical, Inc. | GCJ | Class II | |
| K071742 | Beautifil II | Shofu Dental Corp. | EBF | Class II | |
| K071738 | Exactech Optetrak Proximal Tibial Spacer | Exactech, Inc. | JWH | Class II | |
| K071699 | Amplatzer Vascular Plug II, Models Avp2-003, Avp2-018, Avp2-020, Avp2-022 | Abbott Medical | KRD | Class II | |
| K071682 | Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100 (without Eraser) | Alara, Inc. | MQB | Class II | |
| K071633 | Lanx Deformity System | Lanx, LLC | KWP | Class II | |
| K071496 | Icath, Sterilesure | Colorado Catheter Company, Inc. | NWO | Class II | |
| K071477 | Reverto 55 and 37 Shape Memory Staples | Core Essence Orthopaedics, LLC | JDR | Class II | |
| K071469 | Inolase Serenity Psf ( Pneumatic Skin Flattening) System | Candela Corporation | GEX | Class II | |
| K071410 | Argen Pearl Brand Zirconia | The Argen Corporation | EIH | Class II | |
| K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb Incorporated | HQD | Class II | |
| K071138 | Cranioclamp Bioabsorbable Cranial Bone Flap Fixation System | Prosurg, Inc | GXR | Class II | |
| K070828 | Kd-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon(Tianjin)Electronic&Electrical Apparatus Co. | DXN | Class II | |
| K070826 | Kd-795 Wrist Measurement Electronic Blood Pressure Monitor | Kodon(Tianjin)Electronic&Electrical Apparatus Co. | DXN | Class II | |
| K070151 | Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier | Ethicon Endo-Surgery Inc | OCW | Class II | |
| K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 | Microsurgeon, Inc. | NEY | Class II | |
| K070005 | Hemosil Recombiplastin 2G | Instrumentation Laboratory Co. | GJS | Class II | |
| K063759 | Heatmarker Time Temperature Indicator | Temptime Corporation | OCI | Class II | |
| K063323 | Spectrolyse Pai-1, Model 101201 | Sekisui Diagnostics, LLC | GGP | Class II | |
| K062489 | Apex Hcla Acetabular Cup Liners | Omni Life Science, Inc. | LPH | Class II |