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 |
|---|---|---|---|---|---|
| K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K220187 | Medical Surgical Mask (Model: JM92, JM92B) | Guangdong Jia Mei Biological Technology Co.Ltd | FXX | Class II | |
| K213848 | Medical nitrile examination gloves (Model: JL001) | Guangdong Jiali Pharmaceutical Co.,Ltd | LZA | Class I | |
| K213820 | BALTEUM - ONE™ Lumbar Plate System | Huvexel Co., Ltd. | KWQ | Class II | |
| K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | LLZ | Class II | |
| K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | |
| K212395 | Nebulizer | Shenzhen Homed Medical Device Co Ltd | CAF | Class II | |
| K212263 | Luna G3 BPAP System | 3B Medical Inc | BZD | Class II | |
| K212231 | C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies Ltd | DQA | Class II | |
| K210037 | Pluski Safe 1 Safety IV Catheter | Mediplus (India) Limited | FOZ | Class II | |
| K202437 | Infusion Sets for Single Use | Jiangsu Suyun Medical Materials Co., Ltd. | FPA | Class II | |
| K220655 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | MAX | Class II | |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific Corporation | LOX | Class II | |
| K220519 | Erchonia Zerona Z-Bed | Erchonia Corporation | OLI | Class II | |
| K220453 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | |
| K220354 | Disposable Medical Synthetic Nitrile Examination Gloves | Niujian Technology Co., Ltd. | LZA | Class I | |
| K220207 | Mobility Scooter, Model W3468 | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K220196 | Steth IO Spot | Stratoscientific | DQD | Class II | |
| K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | QJP | Class II | |
| K213492 | Dib UltraNav Transseptal Catheter System | Dib Ultranav Medical, LLC | DYB | Class II | |
| K213461 | AviClear Laser System | Cutera Inc | GEX | Class II | |
| K212916 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Rimba Glove Sdn Bhd | LZA | Class I | |
| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. dba Alio | DRG | Class II | |
| K202903 | Surgical Face Mask | Rizhao Sanqi Medical & Health Articles Co., Ltd | FXX | Class II | |
| K220501 | Pounce Thrombectomy System | Surmodics, Inc. | QEW | Class II | |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | KWY | Class II | |
| K220178 | Total Immunoglobulin E (IgE) | Siemens Healthcare Diagnostics Inc. | DGC | Class II | |
| K214101 | Project E Beauty LED Light Therapy Mask (Model: PE730) | Duplex International Trading Limited | OHS | Class II | |
| K213860 | ArthroFree Wireless Surgical Camera System | Lazurite Holdings, LLC | GCJ | Class II | |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton Dickinson & Co | FQH | Class II | |
| K213592 | Iridex 810 Laser | Iridex Corporation | HQF | Class II | |
| K213568 | DRX-Rise Mobile X-ray System | Eastman Kodak Company | IZL | Class II | |
| K212726 | Disposable Medical Surgical Mask | Hubei Huaqiang High-Tech Co., Ltd. | FXX | Class II | |
| K212626 | PathBuilder Transseptal Guiding Introducer | Shanghai MicroPort EP MedTech Co., Ltd. | DYB | Class II | |
| K212625 | PathBuilder Transseptal Needle | Shanghai MicroPort EP MedTech Co., Ltd. | DRC | Class II | |
| K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K220511 | Medline UNITE IM Fibula Implant | MEDLINE INDUSTRIES, LP - Northfield | HWC | Class II | |
| K220181 | StealthFix Intraosseous Fixation System | Medartis AG | JDR | Class II | |
| K214103 | Shani Darden LED light therapy mask | Harpar Grace International | OLP | Class II | |
| K214039 | Logiq P10, Logiq P9, Logiq P8 | GE Healthcare | IYN | Class II | |
| K213678 | Powder Free Blue Nitrile Examination Gloves | Lienteh Technology Sdn Bhd | LZA | Class I | |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Amsino International, Inc. | NGT | Class II | |
| K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | IYN | Class II | |
| K210693 | Plexr Plus | Gmv S.r.l. | GEI | Class II | |
| K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | CGX | Class II | |
| K200828 | Athelas Home | Athelas | GKZ | Class II | |
| K220199 | AFFINITY Proximal Tibia System | Techfit Digital Surgery, Inc. | HRS | Class II | |
| K213721 | BriefCase | Aidoc Medical Ltd. | QAS | Class II |