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 |
|---|---|---|---|---|---|
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi Inc. | EFB | Class I | |
| K241825 | Microwave Ablation Antennas | Canyon Medical Inc. | NEY | Class II | |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sol-Millennium Medical, Inc. | FMF | Class II | |
| K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | |
| K240722 | Derma-R Cream (Derma-R Cream) | Raya Pharmaceuticals LLC | FRO | Unclassified | |
| K240604 | Mtone Evo (Mtone Evo) | M&T SRL | GEX | Class II | |
| K240420 | NeuroField Analysis Suite | Neurofield, Inc. | OLU | Class II | |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. | JDS | Class II | |
| K240036 | PIUR tUS Infinity | Piur Imaging GmbH | QIH | Class II | |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | FPA | Class II | |
| K234108 | ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) | Energy Resources International Co., Ltd. | IZL | Class II | |
| K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | HBC | Class II | |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | DSH | Class II | |
| K242509 | HAnano InterFuse(R) Modular Interbody | Next Orthosurgical | MAX | Class II | |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | MUI | Class II | |
| K242162 | Coconut Hybrid | Good Clean Love, Inc. | NUC | Class II | |
| K241709 | Pectus Blu Support Bar System | Biomet Microfixation | HRS | Class II | |
| K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corp. | BZR | Class II | |
| K240901 | Stethophone | Sparrow Acoustics Inc. | DQD | Class II | |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | EGS | Class I | |
| K234096 | MonoStereo | Medicaltek Co. Ltd | EOB | Class II | |
| K241784 | Arrow® Nitinol Wire | Teleflex Medical | DQX | Class II | |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed, Ltd. | NDN | Class II | |
| K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions LLC | KTT | Class II | |
| K241424 | InnoCare Specialty Foley Catheter | InnoCare Urologics | EZL | Class II | |
| K241123 | Perpak™ Sterilization Tyvek Pouch | Km Corp. | FRG | Class II | |
| K234153 | EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) | Edgelife Technologies, LLC | IYN | Class II | |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | NHA | Class II | |
| K233064 | Copra Supreme | Whitepeaks Dental Solutions GmbH | EIH | Class II | |
| K231893 | LOWTEM Crystal 120 | Lowtem Co., Ltd. | MLR | Class II | |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene LLC | FRC | Class II | |
| K242186 | Neo Sculptor (OF-NEO001) | Ofan Intelligent Technology (Guangzhou) Co. Ltd. | NGX | Class II | |
| K241942 | TriMed Bridge Plates | Trimed Inc | HRS | Class II | |
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 | Togo Medikit Co., Ltd. | DYB | Class II | |
| K240689 | Robin's Egg | Telebrands Corp. | OAP | Class II | |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | Kulzer GmbH | EBF | Class II | |
| K240373 | Air compression Leg Massager (MM0520, MM0521, MM0522) | Zhangzhou Easepal Medical Science and Technology Co.,Ltd. | IRP | Class II | |
| K240293 | Sts | Techbopulm, Ltd. | BZC | Class II | |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | PKL | Class II | |
| K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc | MAX | Class II | |
| K234132 | Medline Reusable Sterilization Wrappers | MEDLINE INDUSTRIES, LP - Northfield | FRG | Class II | |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | DZL | Class II | |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | OLO | Class II | |
| K241771 | Liftendo; Liftendo 2.0 | Medical San Industria de Equipamentos Medicos Ltda | GEX | Class II | |
| K241762 | OneMark | View Point Medical, Inc. | NEU | Class II | |
| K241379 | Powered Wheelchair (NXN20-205, NXN20-205M) | Zhejiang Nysin Medical Co., Ltd. | ITI | Class II | |
| K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated | SBA | Class II | |
| K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II |