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 |
|---|---|---|---|---|---|
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | Lumenis Ltd | GEX | Class II | |
| K170021 | SMV Scientific Cannulated Screws | Smv Scientific | HWC | Class II | |
| K163553 | Powder Free Nitrile Patient Examination Gloves, Blue | Hebei Titans Medical Supply Technology Group., Ltd. | LZA | Class I | |
| K163394 | Hybrid3D | Hermes Medical Solutions AB | KPS | Class II | |
| K161689 | OSSTEM Implant System - Abutment | OSSTEM Implant Co., Ltd. | NHA | Class II | |
| K170446 | LT-300 SD Digital Video Colposcope | Lutech Industries | HEX | Class II | |
| K171152 | Stryker Universal Neuro III System AXS Screw | Stryker Corp. | HBW | Class II | |
| K170908 | Pk Aim | Gyrus ACMI, Inc. | GEI | Class II | |
| K170874 | Eko Model E5 System (EME5), Eko DUO | Eko Devices, Inc. | DQD | Class II | |
| K170752 | OEC Elite | GE Healthcare | OWB | Class II | |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | Bio-Rad Laboratories Inc. | PUQ | Class II | |
| K170322 | Catalys Precision Laser System | Advanced Medical Optics, Inc. | OOE | Class II | |
| K170303 | E5 Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | |
| K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc | PGW | Class II | |
| K163644 | Nihon Kohden QP-160AK EEG Trend Program | Nihon Kohden Corp. | OMA | Class II | |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | JDX | Class II | |
| K163564 | Slit Lamp Sl-2000 | Nidek Co., Ltd. | HJO | Class II | |
| K163261 | AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | FZP | Class II | |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | Sol-Millennium Medical, Inc. | JKA | Class II | |
| K162542 | OsteoMed PINNACLE Driver | Osteomed | HBE | Class II | |
| K162212 | Divergence-L Anterior/oblique Lumbar Fusion System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K161813 | Frova Intubating Introducer | William Cook Europe ApS | BTR | Class II | |
| K161807 | Beamscan | Ptw-Freiburg Physikalisch Technische-Werksraetten | IYE | Class II | |
| K160677 | Microruptor 6 | Meridian AG | GEX | Class II | |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | Thayer Medical Corportation | NVP | Class II | |
| K171165 | SmartByte Device | Scientific Intake | ONY | Class II | |
| K171139 | LaparoLight Veress Needle | Buffalo Filter Co., Inc. | HIF | Class II | |
| K171135 | Lipogems System | Lipogems International S.p.A. | MUU | Class II | |
| K170804 | The Solstice OCT System | Life Spine | NKG | Class II | |
| K170639 | HEALIX ADVANCE Anchor with PERMATAPE Suture | Medos International SARL | MAI | Class II | |
| K162716 | bibag | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K161272 | Supreme and Response Electrophysiology Catheters | Medline ReNewal | NLH | Class II | |
| K160567 | Barone Jejunostomy Catheter Set | Cook Incorporated | KNT | Class II | |
| K160509 | Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Cook Incorporated | KNT | Class II | |
| DEN170019 | Vitamin D 200M Assay for the Topaz System | AB Sciex, LLC | PSL | Class II | |
| K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | DQO | Class II | |
| K171138 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | MQB | Class II | |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | DRT | Class II | |
| K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | A&D Company, Ltd. | DXN | Class II | |
| K170195 | QuantX | Quantitative Insights, Inc. | LLZ | Class II | |
| K170082 | Test of Variables of Attention (T.O.V.A.) Version 9.0 | The Tova Company | LQD | Unclassified | |
| K170078 | Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley | Medisono, LLC | IYN | Class II | |
| K163669 | Humeris Shoulder | Fx Shoulder Solutions SAS | PHX | Class II | |
| K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | KLW | Class II | |
| K162378 | FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. | LTJ | Class II | |
| K161601 | Dynamika | Image Analysis, Inc. | LLZ | Class II | |
| K160398 | MRI Compatibility for Existing Zimmer Dental Implant Systems | ZimVie US Corp LLC | DZE | Class II | |
| K153748 | AirLife Misty Finity Nebulizer | Care Fusion | CAF | Class II | |
| K171327 | Tyber Medical Wedge System | Tyber Medical | PLF | Class II | |
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho-Clinical Diagnostics, Inc. | JIT | Class II |