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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream | INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. | LCX | Class II | |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics Inc. | MOI | Class II | |
| K192675 | VariAx Foot | Stryker Corp. | HRS | Class II | |
| K192603 | Spes Medica Subdermal Needle Electrodes | Spes Medica S.P.A | GXZ | Class II | |
| K192508 | Medsynapse Ris Pacs & Medsynapse VNA | Medsynaptic Private Ltd. | LLZ | Class II | |
| K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | HIR | Class II | |
| K192260 | everX Flow | GC America Inc. | EBF | Class II | |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | Elekta Limited | IYE | Class II | |
| K192207 | Trevo NXT ProVue Retriever | Stryker Corp. | POL | Class II | |
| K192157 | 6450 Ultrasound system | Esaote S.p.A. | IYN | Class II | |
| K192126 | AMIStem-P Short Neck | Medacta International SA | LZO | Class II | |
| K192122 | Trevo Trak 21 Microcatheter | Stryker Corp. | DQO | Class II | |
| K191903 | BruxZir GT (Gum Tissue) Color | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K191754 | Hair Growth System | Kunshan Bella Optical Technology Co., Ltd. | OAP | Class II | |
| K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.p.A. | PHX | Class II | |
| K191734 | MatriStem UBM Pericardial Patch | ACell, Inc | PSQ | Class II | |
| K191236 | 3M™ Attest™ Steam Chemical Integrators | 3M Company | JOJ | Class II | |
| K191103 | Parkell Desensitizer Gel | Parkell, Inc. | EJK | Class II | |
| K191075 | Healy | TimeWaver Production GmbH | NUH | Class II | |
| K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | |
| K190977 | Navina Smart System, Navina Classic System | Dentsply Sirona Inc | KNT | Class II | |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | KCI USA, Inc. | OMP | Class II | |
| K190518 | Color Liquid, Vita Liquid | Zirkonzahn SRL | EIH | Class II | |
| K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | Intelligent Endoscopy | FDI | Class II | |
| K190331 | Applied Medical Laparoscopic Linear Cutter | Applied Medical Resources Corp | GDW | Class II | |
| K171899 | Revitalair 430F | Oxavita S.r.l. | CBF | Class II | |
| K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | BIOTRONIK AG | DQY | Class II | |
| K192625 | PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company | DQY | Class II | |
| K192592 | Axis Plating System | Extremity Medical, LLC | HRS | Class II | |
| K192480 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | KRD | Class II | |
| K192299 | LZI Cotinine II Enzyme Immunoassay | Lin-Zhi International Inc | MKU | Class I | |
| K192266 | M. Blue Adjustable Shunt System | Aesculap Inc | JXG | Class II | |
| K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | US Medical Innovations, LLC | GEI | Class II | |
| K192061 | SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K191488 | SAM IO Intraosseous Access System | Sam Medical Products | FMI | Class II | |
| K191464 | Asahi PTCA Guide Wire Asahi SION Series | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K190439 | Engage™ Partial Knee System | Engage Uni, LLC | NJD | Class II | |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | OraLabs, Inc. | LFD | Unclassified | |
| K192955 | Penumbra LP Coil System | Penumbra Inc. | HCG | Class II | |
| K192792 | TranS1 AxiaLIF Plus System | TranS1 | KWQ | Class II | |
| K192672 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | OUO | Class II | |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/L | FUJIFILM Corporation | FDF | Class II | |
| K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System | Medos International SARL | MRW | Unclassified | |
| K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona Inc | EBZ | Class II | |
| K190497 | Ziehm 8000 | Ziehm Imaging GmbH | OWB | Class II | |
| K181953 | SDS1.2 dental implant | SDS Swiss Dental Solutions | DZE | Class II | |
| DEN180062 | EchoTip Insight Portosystemic Pressure Gradient Measuring System | Cook Ireland Ltd. | QIJ | Class II | |
| K192643 | Dannik Laparoscopic Suction Irrigation System | Dannik | GCJ | Class II | |
| K192573 | Dolphin Medical Imaging USB Ultrasound System | Dolphin Medical Imaging, LLC | IYO | Class II |