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 |
|---|---|---|---|---|---|
| K182329 | SureCure Orthodontic Aligner System | Digital Orthodontic Care | NXC | Class II | |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K182030 | Faros Mobile | Bittium Biosignals Ltd. | MLO | Class II | |
| K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | DQK | Class II | |
| K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | Edwards Lifesciences LLC | KRA | Class II | |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage System | Neurostructures, Inc. | ODP | Class II | |
| K180949 | Steribite | Rjr Surgical, Inc. | HAE | Class II | |
| K180732 | MiroCam Capsule Endoscope System | IntroMedic Co., Ltd. | NEZ | Class II | |
| K180631 | Silk Voice | Sofregen Medical, Inc. | MIX | Class II | |
| K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab SpA | FLL | Class II | |
| K173917 | neoClose PDS | Neosurgical, Ltd. | GCJ | Class II | |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | DiaSorin Molecular LLC | NJR | Class I | |
| K182220 | Curbell branded Patient Monitoring Cables | Curbell Medical Products, Inc. | DSA | Class II | |
| K182162 | OptiBond eXTRa Universal | Sybron Dental Specialties, Inc. | KLE | Class II | |
| K180683 | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | Certa Dose | PQX | Class II | |
| K180381 | Powder Free Vinyl Patient Examination Gloves | Shanxi Hongjin Plastic Technology Co., Ltd | LYZ | Class I | |
| K173001 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K172999 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | LLZ | Class II | |
| K182451 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider | Medtronic, Inc. | GEI | Class II | |
| K182444 | ERBEFLO Olympus Scope Port Connector | Erbe USA Inc | OCX | Class II | |
| K182442 | MiniGuard Arterial Safety Valve | Quest Medical, Inc | MJJ | Class II | |
| K182425 | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co. KG | GWO | Class II | |
| K182279 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | |
| K182216 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | |
| K181939 | icobrain | icometrix | LLZ | Class II | |
| K181934 | Vivid T8, Vivid T9 | GE Healthcare | IYN | Class II | |
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System | Globus Medical, Inc. | KWQ | Class II | |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | MicroAire Surgical Instruments, LLC | HRX | Class II | |
| K181757 | Günther Tulip® Vena Cava Filter Retrieval Set | Cook Incorporated | MMX | Class II | |
| K181613 | MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K180838 | SaliPen | Saliwell Ltd. | LTF | Class II | |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | MEDLINE INDUSTRIES, LP - Northfield | FAD | Class II | |
| K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | DXN | Class II | |
| K173857 | Elecsys Tacrolimus | Roche Diagnostics GmbH | MLM | Class II | |
| K172668 | W Zirconia Implants | TAV Medical | DZE | Class II | |
| DEN170049 | Innovo | Bio-Medical Research, Ltd. | QAJ | Class II | |
| K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience Inc | LYR | Class I | |
| K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM | Stryker Corp. | GCJ | Class II | |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | DDG | Class II | |
| K181781 | DynaClipTM Bone Staple | Medshape, Inc. | JDR | Class II | |
| K181288 | Athelas One | Athelas | GKZ | Class II | |
| K181258 | ConnectedOR Hub with Device and Voice Control | Stryker Corp. | GCJ | Class II | |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | GBM | Class II | |
| K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | MQV | Class II | |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | NQQ | Class II | |
| K182596 | Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | |
| K182557 | MTS Eravacycline 0.002 - 32 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K182427 | Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | |
| K182405 | Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. | QDL | Class II | |
| K182270 | Cellene CO2 Laser System | Bio-Med USA, Inc. | GEX | Class II |