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 |
|---|---|---|---|---|---|
| K261279 | DeltaNEC Interbody System | Nexus Spine, L.L.C. | OVE | Class II | |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | IOR | Class I | |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | IOR | Class I | |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical a/S | QIH | Class II | |
| K254287 | Medline Reusable Blood Pressure Cuff | MEDLINE INDUSTRIES, LP - Northfield | DXQ | Class II | |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | NUC | Class II | |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | LLZ | Class II | |
| K253176 | TearView | Beyond 700 Pty, Ltd. | HKI | Class II | |
| K253148 | RX-1 Sleep | Vivaquant, Inc. dba Rhythm Express | MNR | Class II | |
| K260369 | Dynamis Robotic Surgical System | Lem Surgical Inc | OLO | Class II | |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | QIH | Class II | |
| K261707 | MEMO 4D Curve™ Semirigid mitral annuloplasty ring | Corcym Inc. | KRH | Class II | |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | GEX | Class II | |
| K261665 | CORUS™ Navigation System-GN | Providence Medical Technology, Inc. | OLO | Class II | |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K261246 | Srgc-06 | GC America Inc. | EBF | Class II | |
| K261099 | Blood Volume Analyzer (200) | Daxor Corporation | JWO | Class II | |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd | OHS | Class II | |
| K260820 | Vivix-S 4386W (Fxrd-4386Wa) | Vieworks Co., Ltd. | MQB | Class II | |
| K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | QAS | Class II | |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | GEI | Class II | |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical | DHB | Class II | |
| K260190 | Arthur | ROPCA ApS | IYO | Class II | |
| K260178 | Pelvic Muscle Trainer (KM510, KM516B) | Shenzhen Konmed Technology Co., Ltd | KPI | Class II | |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | QME | Class II | |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | LZA | Class I | |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K253776 | Implantmed Plus II & Piezomed Plus II Module | W & H DentalWerk Buermoos GmbH | DZI | Class II | |
| K253678 | MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. | MUE | Class II | |
| K253521 | Ecmt-100 Wmd | Ecm Therapeutics, Inc. | KGN | Unclassified | |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical Inc. | KCT | Class II | |
| K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | EBZ | Class II | |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd | DXN | Class II | |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | GXN | Class II | |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | HSB | Class II | |
| K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | IZL | Class II | |
| K253050 | RadOncAI | Informai | MUJ | Class II | |
| K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | AVALIGN TECHNOLOGIES, Inc. | OVE | Class II | |
| K252839 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | MWJ | Class II | |
| K252066 | inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20) | Vincent Healthcare Products Limited | BZE | Class II | |
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating LLC | QVB | Class II | |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | DZE | Class II | |
| K250806 | Dental Implant System | A.B. Dental Devices Ltd | DZE | Class II | |
| DEN250025 | Syncron-E | Autonomous Healthcare, Inc. | QVC | Class II | |
| K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research & Development Corp. | QFG | Class II | |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | FRO | Unclassified | |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | DQY | Class II | |
| K261570 | Picosure Workstation | Cynosure, LLC | GEX | Class II |