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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K242163 | SmartSurgN Visualization System | SmartsurgN, Inc. | OWN | Class II | |
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd | EBG | Class II | |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | HWC | Class II | |
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies Pty Ltd | LJS | Class II | |
| K260900 | DYNEX® External Fixation Systems | Vilex LLC | KTT | Class II | |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences LLC | DYB | Class II | |
| K253970 | Wovyn Depth Electrode | Sensomedical Labs Ltd | GZL | Class II | |
| K252945 | Novasight Hybrid System | Conavi Medical Inc | OBJ | Class II | |
| K252338 | MySleepDash | Somnetics International, Inc. (dba Transcend Inc) | BZD | Class II | |
| K252334 | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) | Pontemedag | KPI | Class II | |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.injecta, A.S. | FMF | Class II | |
| K252237 | EdgeFlow UW20 | Edgecare Inc. | IYO | Class II | |
| DEN250033 | XplantR Explant Tool | Hjarta Care, LLC | SHR | Class II | |
| K260903 | Hot Pink Pad Warming System | Xodus Medical Inc | DWJ | Class II | |
| K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | QSZ | Unclassified | |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group | OLO | Class II | |
| K254274 | ARx® SAI Implant System | Life Spine | NKB | Class II | |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | QJP | Class II | |
| K254216 | Enso for Migraine | Hinge Health Inc. | PCC | Class II | |
| K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | NUC | Class II | |
| K253907 | Disposable Radiofrequency Cannula | Abbott Medical | GXI | Class II | |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, | Strauss Surgical USA LLC. | FAJ | Class II | |
| K253804 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | Bright Uro, Inc. | EXQ | Class II | |
| K253523 | Freedom DS™ Decompression System | Spinal Simplicity, LLC | HRX | Class II | |
| K253260 | ORIO-3D Cage System | Spinecraft LLC | ODP | Class II | |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | DXT | Class II | |
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | HIF | Class II | |
| K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular Scitech Limited | MOF | Class II | |
| K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | FGE | Class II | |
| K251478 | ClearTip TBNA Type | Finemedix | KTI | Class II | |
| K260938 | Path Bgc | Crossroads Neurovascular | QJP | Class II | |
| K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona Inc | NXC | Class II | |
| K260661 | Midas Restore | Sprintray Inc. | EBF | Class II | |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co.,Ltd. | GEX | Class II | |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | LON | Class II | |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OLI | Class II | |
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton Dickinson & Co | JKA | Class II | |
| K254107 | Refobacin Bone Cement R (110034355) | Biomet France | LOD | Class II | |
| K253573 | ASTar BC G- Kit | Q-linea AB | SAN | Class II | |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | EMA | Class II | |
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products | MLR | Class II | |
| K252774 | Uni-C Cervical Cage System | Zhejiang Decans Medical Devices Co.,Ltd. | OVE | Class II | |
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Ltd. | CDZ | Class I | |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics, Inc. | PHX | Class II | |
| K252258 | Veriqa Rt Epid 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | IYE | Class II | |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies Inc | DQA | Class II |