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 |
|---|---|---|---|---|---|
| K062171 | Emf Pal II Main Generator and Irrigation Units and Accessories | Ortho Development Corp. | GEI | Class II | |
| K061943 | Anatomica Posterior Cervical Fixation System | Anatomica AB | KWP | Class II | |
| K071355 | Smartsponge System | Clearcount Medical Solutions, Inc. | LWH | Class I | |
| K071301 | Antlia I Wound Irrigation System | Innovative Therapies, Inc. | OMP | Class II | |
| K071108 | Texium Syringe | Cardinal Health, Alaris Products | FMF | Class II | |
| K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | FRC | Class II | |
| K070974 | Light Relief, Model Lr150, Lr200 | Light Relief, LLC | ILY | Class II | |
| K070931 | Model Pmt850 | Promedtek, Inc. | ILX | Class II | |
| K070905 | Endosseous Dental Implant System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K070801 | Imm Hypodermic Needle Set | Innovative Medical Manufacturing Co. | FPA | Class II | |
| K070595 | Sporview Steam Self-Contained Biological Indicator | Spsmedical Supply Corp. | FRC | Class II | |
| K070456 | Micrus Courier Enzo Microcatheter 0.017 | Micrus Endovascular Corporation | DQO | Class II | |
| K070431 | Welmed, Inc. Surgical Gowns | Welmed, Inc. | FYA | Class II | |
| K063743 | Rhythm Touch Q 2-Way | Shockim Enterprises, Ltd. | NUH | Class II | |
| K062192 | Ostial Pro Stent Positioning System | Ostial Solutions, LLC | DQX | Class II | |
| K071243 | Metal Hemi Implant | Orthopro, LLC | KWD | Class II | |
| K071135 | Depuy Ci Hip Instrumentation | Depuy Orthopaedics Inc. | HAW | Class II | |
| K070971 | Modification to Sentinel Clin Chem Cal | Sentinel CH SpA | JIX | Class II | |
| K070807 | Cutaneous Electrotherapy and Recording Electrodes; TENS Electrodes | Pepin Mfg., Inc. | GXY | Class II | |
| K070557 | Mp 719 | Marine Polymer Technologies, Inc. | FRO | Unclassified | |
| K070473 | Blood Pressure Monitor, Models Zsbp-Oxx and Zsbp-1Xx | Zen Strong Medical Technology Co., Ltd. | DXN | Class II | |
| K070124 | Gastrostomy Replacement Tube, Model 253 | Degania Silicone, Inc. | KNT | Class II | |
| K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle | Abbott Medical | LJT | Class II | |
| K070050 | Vitality Hip System Model#420 | Encore Medical, LP | LPH | Class II | |
| K063873 | Icare Tonometer Ta01i | Tiolat Oy | HKY | Class II | |
| K063611 | Saline/ Contrast Media Infusion Catheter | Utah Medical Products, Inc | LKF | Class II | |
| K063489 | Stryker Intradiscal RF Generator | Synergetics Inc | GXD | Class II | |
| K063367 | 45L Core Insufflator, Model F114 | Novanta Medical GmbH | HIF | Class II | |
| K063269 | 5Mp Medical Monochrome Reference Display, Model Mdm2010-5Nc | Chi Lin Technology Co., Ltd. | LLZ | Class II | |
| K061323 | Modification to Reliadent Dental Implant System | Bioinfera, Inc. | DZE | Class II | |
| K071314 | Sonoline G20 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K071311 | Neocoil 1.5T 8-Channel Shoulder Array Coil | NeoCoil, LLC | MOS | Class II | |
| K071114 | Syngo Imaging (Version V30) | Siemens AG Medical Solutions | LLZ | Class II | |
| K071099 | Neuro II-Se, Models: or-Dr-or, or-Mb | Imris, Inc. | LNH | Class II | |
| K071078 | .Decimal Range Compensator | .Decimal, Inc. | IXI | Class II | |
| K071054 | Radiodexter, Dextroscope, Dextrobeam, Models 1.0, Mk10, Mk3 & Mk4 | Volume Interactions Pte, Ltd. | LLZ | Class II | |
| K071040 | Wright Model 51 and 52 Sequential Compression Systems | Wright Linear Pump, Inc. | JOW | Class II | |
| K071005 | Heartway Lightweight Power Chair, P15 | Heartway Medical Products Co., Ltd. | ITI | Class II | |
| K070956 | Sea2 Self Etch Adhesive | 3M ESPE Dental Products | KLE | Class II | |
| K070934 | Panosol II Tru-Blu, Model Ubl-417 | National Biological Corp. | FTC | Class II | |
| K070920 | Fuji Ip Cassette Type Pc | FUJIFILM Healthcare Americas Corporation | IYE | Class II | |
| K070831 | Voxar 3D Enterprise with Colonmetrix and Pet/ct Perfusion | Barcoview Mis Edinburgh | LLZ | Class II | |
| K070827 | Karl Storz Scb Interface Control, Model 20090120 | Karl Storz Endoscopy-America, Inc. | ODA | Class II | |
| K070763 | Euroimmun Ana Ifa: Hep-20-10 | Euroimmun US Inc. | DHN | Class II | |
| K070396 | Modification to: Acumen Single-Lumen Delivery Sheath, Models Bls-8-45, Bls-7-45, Bls-6-45 | Acumen Medical, Inc. | DYB | Class II | |
| K070286 | Bio-Console, Model 560 | Medtronic, Inc. | DWA | Class II | |
| K070234 | Jms Sysloc Mini Avf and Apheresis Needle Sets | JMS North America Corp. | MPB | Class II | |
| K070064 | Amylase Eps Reagent | Thermo Fisher Scientific Oy | JFJ | Class II | |
| K063480 | Stryker RF Intradiscal Adaptor, Model 406-750 | Stryker Corp. | GEI | Class II | |
| K062826 | Aos Implant Tubes, Implant Needles & Retaining Bottons | Alpha Omega Services Inc | JAQ | Class II |