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 |
|---|---|---|---|---|---|
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | IPG Medical Corporation | GEX | Class II | |
| K232439 | Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. | NUH | Class II | |
| K230088 | Ankle Truss System (ATS) | 4Web Medical, Inc. | SAI | Class II | |
| K240743 | Peak Universal Bond | Ultradent Products Inc. | KLE | Class II | |
| K240574 | BruxZir® Radiant | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K240537 | Smartxide Pro | El.En S.p.A. | GEX | Class II | |
| K240507 | NuVasive AttraX Scaffold | NuVasive Inc | MQV | Class II | |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory | DXQ | Class II | |
| K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O | GE Medical Systems Information Technologies, Inc. | MWI | Class II | |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | IZI | Class II | |
| K234052 | Access Ferritin | Siemens Healthcare Diagnostics Inc. | JMG | Class II | |
| K234049 | Straumann® BLC and TLC Implants - Line extension | Straumann USA, LLC | DZE | Class II | |
| K234047 | Automatic Registration | Brainlab, Inc. | OLO | Class II | |
| K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | Shenzhen Desida Technology Co., Ltd. | BTA | Class II | |
| K233642 | InMode RF System | Inmode Ltd. | GEI | Class II | |
| K233375 | Tranquil-L Interbody System | Nexus Spine, L.L.C. | MAX | Class II | |
| K233002 | Beed 2,5, Beed 3,8 | Excelsior Resources, LLC | GEI | Class II | |
| K232654 | Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC | LZA | Class I | |
| K232125 | V-Pvp | VITROMED GmbH | MQL | Class II | |
| K231974 | PATHFAST®hs-cTnI-II | Phc Corporation | MMI | Class II | |
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech Co., Ltd. | GXY | Class II | |
| K234024 | HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMF | Class II | |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | PKL | Class II | |
| K233146 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd | DXN | Class II | |
| K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. | EIH | Class II | |
| K232619 | MATRIX HA PEEK Cervical IBF System | Sapphire Medical Group | ODP | Class II | |
| K231843 | ARX Viral Transport Media Collection and Transport System | Arx Sciences | JSM | Class I | |
| K231719 | Medical Surgical Mask | Azur Medical Company, Inc. | FXX | Class II | |
| K240515 | uNion® MAX Cervical Plate System | ulrich medical USA Inc | KWQ | Class II | |
| K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. | OLO | Class II | |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc. | PBF | Class II | |
| K233660 | nCommand Lite System | Ionic Health | LLZ | Class II | |
| K233599 | X-Clever (ASHK100G) | LG Electronics.Inc | LLZ | Class II | |
| K230981 | Meriglu Topical Skin Adhesive | M/s. Meril Endo Surgery Private Limited. | MPN | Class II | |
| K240694 | FORMA Composite (Shade A3D) | Ultradent Products Inc. | EBF | Class II | |
| K240539 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | NKB | Class II | |
| K240466 | STARband 3D | Orthomerica Products, Inc. | OAN | Class II | |
| K240454 | RESPONDER® Polysaccharide Hemostat | Starch Medical Inc. | QSY | Unclassified | |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | DePuy Mitek, Inc. | MAI | Class II | |
| K240430 | Otoport Pro | Otodynamics, Ltd. | EWO | Class II | |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) | Inquis Medical, Inc. | QEW | Class II | |
| K240112 | Light Cure Composite | Sincera Technology (Changchun) Co., Ltd | EBF | Class II | |
| K234115 | APRO 55 Catheter | Alembic LLC | DQY | Class II | |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | WONTECH Co., Ltd. | GEX | Class II | |
| K233986 | BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) | Becton Dickinson & Co | LON | Class II | |
| K233881 | ivWatch® Model 400 | Ivwatch, LLC | PMS | Class II | |
| K233814 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) | 3M Company | FRC | Class II | |
| K233799 | Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | Shenzhen Yuezhongxing Technology Co.,Ltd | DXN | Class II | |
| K233748 | CIARTIC Move (VB10) | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K233747 | Concha Sol Hearing Aids (CL-1001) | Concha Labs | QUH | Class II |