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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc | ETN | Class II | |
| K230777 | Patient Examination Gloves | 3A Glove Sdn. Bhd. | LZA | Class I | |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | DSI | Class II | |
| K230144 | Denti.AI Detect | Denti.ai Technology Inc. | MYN | Class II | |
| K230091 | THE Cover | Purgo Biologics Inc. | NPL | Class II | |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Medimaging Integrated Solution, Inc (Miis) | FAJ | Class II | |
| K223905 | Vivio® LVEDP System | Avicena, LLC | QUO | Class II | |
| K223802 | accufit | Mettler Electronics Corp | IPF | Class II | |
| K221777 | Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. | FMF | Class II | |
| DEN220087 | Edison System | Histosonics, Inc | QGM | Class II | |
| K233044 | Tandem Mobi insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp | IYN | Class II | |
| K232675 | Heating Tens, FT-615 | Hivox Biotek Inc. | NUH | Class II | |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD | bioMerieux, Inc. | JWY | Class II | |
| K232367 | cmAngio® V1.0 | Curemetrix, Inc. | QIH | Class II | |
| K232279 | LifeStyles NRL Textured Condom | Suretex, Ltd. | HIS | Class II | |
| K231078 | All-Suture Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K231001 | DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt. Ltd | MYN | Class II | |
| K230780 | Mfg-05 | Zimmer Medizinsysteme GmbH | KPI | Class II | |
| K230242 | OsteoCentric Dental Implant System | OsteoCentric Technologies,Inc | DZE | Class II | |
| K230070 | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® | Promamedical Inc. | FMI | Class II | |
| K223740 | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science and Technology Co Ltd | CAW | Class II | |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories, Limited | DJG | Class II | |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories, Limited | DJG | Class II | |
| K232844 | The IQoolTM System | Braincool AB | DWJ | Class II | |
| K232767 | Nautilus VF ECMO Oxygenator | MC3, Inc. | BYS | Class II | |
| K232763 | Electrode Handpieces (VCT, RFTV, BMDT series) | RF Medical Co., Ltd | GEI | Class II | |
| K232023 | Momentum Spine | Momentum Health Inc. | LDK | Unclassified | |
| K231567 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) | Better Care Plastic Technology Co., Ltd. | LZA | Class I | |
| K231398 | VUNO Med-DeepBrain | Vuno Inc. | QIH | Class II | |
| K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | |
| K230135 | Copioumed Chemotherapy Isolation Gown | Copioumed International, Inc. | FYC | Class II | |
| DEN230002 | DuraGraft | Marizyme, Inc. | QEJ | Class II | |
| K232918 | enspire 300 Series Automated Endoscope Reprocessor | STERIS Corporation | NZA | Class II | |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | STERIS Corporation | MED | Class II | |
| K232762 | dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) | MOS | Class II | |
| K232722 | endo.digital Platform | Dreamed Diabetes Ltd | QCC | Class II | |
| K232712 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K232406 | Karl Storz Or1™ Scb Control (Wu300) | Karl Storz SE & Co. KG | ODA | Class II | |
| K232230 | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | Zhenjiang Assure Medical Equipment Co Ltd | IOR | Class I | |
| K232094 | Orchid Safety Release ValveTM | Linear Health Sciences LLC | QOI | Class II | |
| K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Anx Robotica Corp. | QKZ | Class II | |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K230085 | Lung-CAD | Imagen Technologies, Inc. | MYN | Class II | |
| K232359 | Surgical face mask | Kingstar Medical (Xianning) Co., Ltd. | FXX | Class II | |
| K232064 | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) | Isikel Manufacturing, LLC | LZA | Class I | |
| K231716 | OsteoFlo® HydroPutty™ | Surgentec LLC | MQV | Class II | |
| K231520 | tmCMF Solution | Techmah Cmf | DZJ | Class II | |
| K230681 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | Central Medicare Sdn Bhd | LZA | Class I | |
| K221972 | Warantec Custom Abutment | WARANTEC Co., Ltd. | NHA | Class II |