FDA decided 3211 premarket notifications (510(k)s) in the last 12 months. Open a product area or a state for every decision in it; the newest 50 are below. Each row links to FDA's own record.
By product area
By state
Nevada, Kansas, Montana, South Dakota, Maine, Kentucky, Mississippi, North Dakota, Idaho, Rhode Island, Iowa, Wyoming, West Virginia, Arkansas, Louisiana, New Mexico
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-03-26 | Restore Robotics | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) QSM | Gastroenterology, Urology | Henderson, Nevada | K252926 |
| 2026-03-25 | Spinepoint, LLC | Flex-Z Cervical Cage ODP | Orthopedic | Reno, Nevada | K252432 |
| 2026-02-20 | Foreo, Inc. | FAQ (LED Panel); FAQ (Dual LED Panel) OHS | General, Plastic Surgery | Las Vegas, Nevada | K253683 |
| 2026-02-13 | Contour Research, LLC | Contour Light (CL-100) OLI | General, Plastic Surgery | Reno, Nevada | K243854 |
| 2026-10-02 | Spinal Simplicity, LLC | Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System PEK | Orthopedic | Overland Park, Kansas | K261607 |
| 2026-04-16 | Spinal Simplicity | Freedom DS Decompression System HRX | Orthopedic | Overland Park, Kansas | K253523 |
| 2025-12-01 | Spinal Simplicity, LLC | Minuteman® G6 MIS Fusion Plate PEK | Orthopedic | Overland Park, Kansas | K253250 |
| 2026-09-02 | ArthroTAK, LLC | ArthroTAK Tendon Anchor Kit MBI | Orthopedic | Missoula, Montana | K262809 |
| 2026-07-09 | PINKSLIP, LLC | PINKSLIP Water-Based Personal Lubricant and Moisturizer NUC | Obstetrics/Gynecology | Whitefish, Montana | K261177 |
| 2026-05-01 | ArthroTAK, LLC | ArthroTAK Tendon Anchor Kit MBI | Orthopedic | Missoula, Montana | K252635 |
| 2026-06-18 | Mastel Surgical | SteriBest® Sterilization Tray System KCT | General Hospital | Rapid City, South Dakota | K253187 |
| 2026-04-30 | Balance Ophthalmics, Inc. | FSYX Ocular Pressure Adjusting Pump QQJ | Ophthalmic | Sioux Falls, South Dakota | K252455 |
| 2025-11-14 | Inanovate, Inc. | Lyme-ID IgG Test; Bio-ID800 LSR | Microbiology | Sioux Falls, South Dakota | K252627 |
| 2026-08-31 | Abbott Diagnostics Scarborough, Inc. | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 OCC | Microbiology | Scarborough, Maine | K262747 |
| 2026-05-19 | Maine Molecular Quality Controls, Inc. | FilmArray TF Control Panel M527 PMN | Microbiology | Saco, Maine | K260577 |
| 2026-08-31 | Aura Wellness, LLC | Nova HD+ SGT | Physical Medicine | Louisville, Kentucky | K262788 |
| 2025-12-02 | Aura Wellness, LLC | Aura Wave SGT | Physical Medicine | Louisville, Kentucky | K250896 |
| 2026-07-24 | Zavation Medical Products, LLC | Tiger 2 System NKB | Orthopedic | Flowood, Mississippi | K253943 |
| 2025-11-24 | Precision Spine, Inc. | Dakota LP System ODP | Orthopedic | Pear, Mississippi | K250769 |
| 2026-05-12 | CorVent® Medical, Inc. | CorVision® (91-205-Z0014) MOD | Anesthesiology | Fargo, North Dakota | K260051 |
| 2025-11-07 | Bench7, Inc. | SugarBug (1.x) MYN | Radiology | Bismarck, North Dakota | K250264 |
| 2026-02-10 | Fourth Axis, LLC | LANDR Contact LENS Case LRX | Ophthalmic | Boise, Idaho | K252175 |
| 2025-12-12 | Vault Paragon Group, Inc. | VaporShield MEG | General Hospital | Garden City, Idaho | K250847 |
| 2026-09-28 | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | Phasix ST Parastomal Hernia Mesh OWT | General, Plastic Surgery | Warwick, Rhode Island | K261543 |
| 2026-09-24 | CIVCO Medical Instruments Co., Inc. | Align® Cover and Pad Guidance Tool ITX | Radiology | Coralville, Iowa | K260114 |
| 2026-06-11 | Endeavor Commerce, LLC | Snorbliss® Anti-Snoring Device LRK | Dental | Sheridan, Wyoming | K261251 |
| 2026-04-27 | NovoSource | NovoKnee (SteriKnee) JWH | Orthopedic | Morgantown, West Virginia | K261032 |
| 2026-02-19 | Efofex, Inc. | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) FXX | General, Plastic Surgery | Rogers, Arkansas | K253398 |
| 2025-12-22 | Lacerta Life Science | LacertaMatrix KGN | Unknown | Broussard, Louisiana | K252673 |
| 2025-11-25 | Indica Labs, LLC | HALO AP Dx QKQ | Pathology | Albuquerque, New Mexico | K252762 |
Latest decisions
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-10-02 | Cognition Medical Corp. | OAB Delivery Catheter QJP | Cardiovascular | Atlanta, Georgia | K253422 |
| 2026-10-02 | VPIX Medical, Inc. | cCeLL405 QFX | Neurology | KR | K254030 |
| 2026-10-02 | Aesculap, Inc. | Ventricular Catheters, Thomale Catheter JXG | Neurology | Center Valley, Pennsylvania | K260044 |
| 2026-10-02 | Argus Cognitive, Inc. | Neurora QPF | Neurology | Hanover, New Hampshire | K260064 |
| 2026-10-02 | Roche Diagnostics | Elecsys EBV EBNA IgG LSE | Microbiology | Indianapolis, Indiana | K260221 |
| 2026-10-02 | Roche Diagnostics | Elecsys EBV VCA IgG LSE | Microbiology | Indianapolis, Indiana | K260232 |
| 2026-10-02 | Roche Diagnostics | Elecsys EBV IgM LJN | Microbiology | Indianapolis, Indiana | K260233 |
| 2026-10-02 | Shenzhen Lifotronic Technology Co., Ltd. | H100Plus Hemoglobin Testing System PDJ | Clinical Chemistry | CN | K260468 |
| 2026-10-02 | Ovesco Endoscopy AG | stentFIX System Set (100.50n) PKL | Gastroenterology, Urology | DE | K260487 |
| 2026-10-02 | Shenzhen Ninenovo Technology Limited | Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) DQA | Cardiovascular | CN | K260490 |
| 2026-10-02 | I-Sens, Inc. | CVS Advanced PLUS Blood Glucose Monitoring System NBW | Clinical Chemistry | KR | K260689 |
| 2026-10-02 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Lung Guidance QJU | Radiology | Waukesha, Wisconsin | K261042 |
| 2026-10-02 | GS Medical Co., Ltd. | AnyPlus II Spinal Fixation System NKB | Orthopedic | KR | K261217 |
| 2026-10-02 | Spinal Simplicity, LLC | Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System PEK | Orthopedic | Overland Park, Kansas | K261607 |
| 2026-10-02 | Tdm Co., Ltd. | TDM Large Bone Plate and Screw System HRS | Orthopedic | KR | K261611 |
| 2026-10-02 | Anrei Medical (Hz) Co., Ltd. | Hemostatic Clip PKL | Gastroenterology, Urology | CN | K261741 |
| 2026-10-02 | Gelesis SRL | Plenity-V (MC0979 / GS110) QFQ | Gastroenterology, Urology | IT | K261783 |
| 2026-10-02 | Steris | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor FEB | Gastroenterology, Urology | Mentor, Ohio | K261791 |
| 2026-10-02 | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 IYN | Radiology | Waukesha, Wisconsin | K261933 |
| 2026-10-02 | Remedi, Inc. | REMEX-T(K)100C IZL | Radiology | KR | K261943 |
| 2026-10-02 | Barco NV | Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) PGY | Radiology | BE | K262412 |
| 2026-10-02 | Lg Electronics.Inc | Medical Monitor (32MD08WC) PGY | Radiology | KR | K262985 |
| 2026-10-02 | Response Ortho Solutions, LLC | Response Ortho Smart Fixator - Hexapod System KTT | Orthopedic | Boynton Beach, Florida | K263083 |
| 2026-10-02 | Encore Medical L.P. | AltiVate Reverse® Glenosphere with RAVN Technology PHX | Orthopedic | Austin, Texas | K263086 |
| 2026-10-02 | ZSFab, Inc. | ZSAlign Cervical Interbody System OVE | Orthopedic | Waltham, Massachusetts | K263113 |
| 2026-10-02 | OsteoCentric Technologies | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts HWC | Orthopedic | Logan, Utah | K263116 |
| 2026-10-02 | Cepheid® | Xpert Xpress CoV-2/Flu plus QOF | Microbiology | Sunnyvale, California | K263120 |
| 2026-10-01 | FDC Technology Industry Co. | Firstar Dental Electric Motor EBW | Dental | Kent, Washington | K260027 |
| 2026-10-01 | FDC Technology Industry Co. | Firstar Dental Handpieces EFB | Dental | Kent, Washington | K260029 |
| 2026-10-01 | bioMerieux, Inc. | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) LON | Microbiology | Hazelwood, Missouri | K260283 |
| 2026-10-01 | Shenzhen Brav Electronic Technologies Co., Ltd. | Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206) DXN | Cardiovascular | CN | K260470 |
| 2026-10-01 | Airs Medical, Inc. | SwiftSight-BodyComposition LNH | Radiology | KR | K261612 |
| 2026-10-01 | Yty Industry (Manjung) Sdn Bhd | Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink LZA | General Hospital | MY | K262208 |
| 2026-10-01 | Microport Orthopedics, Inc. | NEXUS® Hip Stem LZO | Orthopedic | Arlington, Tennessee | K262473 |
| 2026-10-01 | Centerline Biomedical | Intra-Operative Positioning System (IOPS) and IOPS Visionary System DQK | Cardiovascular | Warrensville Heights, Ohio | K263016 |
| 2026-10-01 | Tdm Co., Ltd. | NOVIX Pedicle Screw System NKB | Orthopedic | KR | K263062 |
| 2026-10-01 | Sorin Group Italia S.R.L. | Dual Stage Venous Cannulae DWF | Cardiovascular | IT | K263092 |
| 2026-09-30 | Medical AI Co., Ltd. | ECG Analysis Software (AiTiALVSD) QYE | Cardiovascular | KR | K254302 |
| 2026-09-30 | Elos Medtech Pinol A/S | Elos Accurate Hybrid Base NHA | Dental | DK | K261327 |
| 2026-09-30 | Barco N.V. | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). DXJ | Cardiovascular | BE | K261469 |
| 2026-09-30 | Qpix Solutions, Inc. | EzSensor HD MUH | Dental | Morrisville, North Carolina | K261663 |
| 2026-09-30 | CyDen Limited | Braun Aura 7 (6041) OHT | General, Plastic Surgery | GB | K261975 |
| 2026-09-30 | Danumed Medizintechnik GmbH | danumed StomaMeter KNT | Gastroenterology, Urology | DE | K262038 |
| 2026-09-30 | Brainlab SE | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine OLO | Neurology | DE | K262257 |
| 2026-09-30 | Mui Scientific, Inc. | Rapid Barostat Bag (RBB) Pump and Catheter System FFX | Gastroenterology, Urology | CA | K262621 |
| 2026-09-30 | Duet Spine Holdings, LLC | Duet Spinal Fixation System NKB | Orthopedic | Winona Lake, Indiana | K262712 |
| 2026-09-30 | Revvity, Inc. | Eonis SMA kit QUE | Immunology | Waltham, Massachusetts | K262893 |
| 2026-09-30 | Fussen Technology Co., Ltd. | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) OAS | Radiology | CN | K263033 |
| 2026-09-30 | Centers for Disease Control and Prevention | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) OZE | Microbiology | Atlanta, Georgia | K263035 |
| 2026-09-30 | Spinal Alignment Solutions, Inc. | SAS MIS Pelvic Incidence Rods NKB | Orthopedic | Wilmington, North Carolina | K263172 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
Permanent URL:
https://mentionfox.com/fda/510kLast updated 2026-10-18
FDA 510(k) device clearances: 3211 decisions in the last 12 months, by product area and state. MentionFox, 2026-10-18. https://mentionfox.com/fda/510k