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 |
|---|---|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc | HAW | Class II | |
| K252926 | Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) | Restore Robotics | QSM | Class II | |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc | HRS | Class II | |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | HRS | Class II | |
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | DQO | Class II | |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | GEI | Class II | |
| K253615 | Invictus Bands System | Alphatec Spine, Inc. | OWI | Class II | |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | LHN | Class II | |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | MEDLINE INDUSTRIES, LP - Northfield | BZE | Class II | |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd | EOB | Class II | |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou) Inc. | FMI | Class II | |
| K252432 | Flex-Z™ Cervical Cage | Spinepoint, LLC | ODP | Class II | |
| K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch & Lomb Incorporated | HQC | Class II | |
| K252037 | CUVIS-joint (CJ150) | CUREXO, Inc. | OLO | Class II | |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | FRO | Unclassified | |
| K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | QXA | Class II | |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Healthcare | IYN | Class II | |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | MUE | Class II | |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | AAP Implantate AG | HRS | Class II | |
| K254012 | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | ITI | Class II | |
| K253198 | NanoKnife Generator (H78720300351US0) | Boston Scientific Corporation | OAB | Class II | |
| K253047 | Pressone™ | Nipro Medical Corporation | FMI | Class II | |
| K252421 | Jlk-Ncct | JLK, Inc. | QAS | Class II | |
| K252169 | Access BNP II | Siemens Healthcare Diagnostics Inc. | NBC | Class II | |
| K252099 | Trinias | Shimadzu Corp. | OWB | Class II | |
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd | OHS | Class II | |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics | KTT | Class II | |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc | HRS | Class II | |
| K254275 | HyperSuture All Green Extension Line | Threadstone LLC | GAT | Class II | |
| K254166 | MDx-Chex for BCN | Streck LLC | PMN | Class II | |
| K253686 | True Definition DL | GE Healthcare Japan Corporation | JAK | Class II | |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems Ltd. | DZE | Class II | |
| K260585 | Noxturnal Web | Nox Medical Ehf | OLV | Class II | |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | GGW | Class II | |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | FMD Co., Ltd. | DQX | Class II | |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | MOS | Class II | |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | OZT | Class II | |
| K254208 | FLOWRUNNER Aspiration System | Expanse Medical Inc. | QEZ | Class II | |
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone, Inc. | PIF | Class II | |
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | EHD | Class II | |
| K253849 | Electric wheelchair (JJW-7002, JJW-7003) | Zhejiang J&J Mobility Co., Ltd | ITI | Class II | |
| K253604 | TiLink-L Navigation Instruments | Surgentec LLC | OLO | Class II | |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K253520 | Photonova Spectra, Photonova Spectra Select | GE Healthcare | JAK | Class II | |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | OBP | Class II | |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | EMA | Class II | |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | OBP | Class II | |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corp. | EOB | Class II |