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 |
|---|---|---|---|---|---|
| K202831 | The iMask Child's Face Mask | Pac-Dent Inc. | OXZ | Class II | |
| K202802 | TT Electric Breast Pump, TT Double Electric Breast Pump | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | HGX | Class II | |
| K200748 | Visby Medical Sexual Health | Visby Medical, Inc. | QEP | Class II | |
| K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | MVM | Class II | |
| K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical Inc. | PKL | Class II | |
| K212134 | Diagnostic X-ray System/PLX5200A | Nanjing Perlove Medical Equipment Co., Ltd. | IZL | Class II | |
| K212051 | Rfa-1717Dig, Rfa-1717Dic | Astel, Inc. | MQB | Class II | |
| K211616 | ExcelsiusHub | Globus Medical, Inc. | OLO | Class II | |
| K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | Depuy Ireland UC | JWH | Class II | |
| K211500 | AMSCO 600 Medium Steam Sterilizer | STERIS Corporation | FLE | Class II | |
| K211451 | Disposable Surgical Mask (non sterile) | Qinhuangdao Taizhi Medical Technology Co., Ltd | FXX | Class II | |
| K211444 | CellFX System | Pulse Biosciences, Inc. | GEI | Class II | |
| K211362 | Scar 3 | El.en. Electronic Engineering SpA | GEX | Class II | |
| K210936 | Elvie Stride | Chiaro Technology Limited | HGX | Class II | |
| K210838 | Prowler Select Plus; Prowler Ex | Medos International SARL | KRA | Class II | |
| K210792 | Auxein Nailing System | Auxein medical Private Limited | HWC | Class II | |
| K210790 | Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | PHX | Class II | |
| K203357 | Hvt 2.0 | Vapotherm Inc. | BTT | Class II | |
| K203344 | Premilled Titanium Block System | Innobiosurg Co., Ltd. | NHA | Class II | |
| K202916 | Balloon Guiding Catheter | Shanghai Heartcare Medical Technology Corporation Limited | QJP | Class II | |
| K202148 | E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) | Fit-Pro, Ltd. | NGX | Class II | |
| K212027 | TurboHawk Plus Directional Atherectomy System | Medtronic, Inc. | MCW | Class II | |
| K211516 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | Tangshan Hongyun Plastic Products Co., Ltd. | LYZ | Class I | |
| K211515 | Nitrile Examination Gloves | Beijing Reagent Latex Products Co., Ltd. | LZA | Class I | |
| K211501 | Advantage-C PEEK Cervical lnterbody Fusion Device | Lntelivation, LLC | ODP | Class II | |
| K210897 | Disposable Nitrile Examination Gloves | Shandong DS Safety Technology Co., Ltd. | LZA | Class I | |
| K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | BZD | Class II | |
| K210674 | Shoulder Pacemaker | NCS Lab SRL | IPF | Class II | |
| K210619 | Skr 3000 | Konica Minolta, Inc. | MQB | Class II | |
| K210464 | Auto Disable Syringe | Anhui Tiankang Medical Technology Co., Ltd. | FMF | Class II | |
| K203739 | ELAN 4 Electro Motor System | Aesculap Inc | HBE | Class II | |
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics Inc. | MBL | Class II | |
| K212367 | IMRIS iMRI 3T V | IMRIS Imaging, Inc. | LNH | Class II | |
| K212324 | RenovoCath | RenovoRx, Inc. | MJN | Class II | |
| K212105 | 6543Z, 4386Z, 4343Z, 4343Zf, 3543Z, 3543Zf, 3030Z, 3025Z, 3025Zf | Pzmedical Technology Co., Ltd. | MQB | Class II | |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories | MSS | Class I | |
| K211793 | EzOrtho | Ewoosoft Co., Ltd | LLZ | Class II | |
| K203396 | Deka Smartperio | El.en. Electronic Engineering SpA | NVK | Class II | |
| K202745 | Disposable medical face mask | Ningbo Jingeao Electronics, Inc. | FXX | Class II | |
| K201400 | npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ | Aatru Medical, LLC | QPX | Class II | |
| K200657 | SmartGuard Anti-Snoring Device | Smartguard RX Inc | LRK | Class II | |
| DEN210003 | SureTune4 Software | Medtronic Neuromodulation | QQC | Class II | |
| K202532 | Disposable Surgical Gowns | Anhui Medpurest Medical Technology Co.,Ltd | FYA | Class II | |
| K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | HRS | Class II | |
| K212294 | Ethos Treatment Management, Ethos Treatment Planning | Varian Medical Systems, Inc. | IYE | Class II | |
| K211916 | IPS e.max One | Ivoclar Vivadent, Inc. | EIH | Class II | |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | HSX | Class II | |
| K211846 | Discovery MI Gen2 | GE Healthcare | KPS | Class II | |
| K211791 | Ez3D-i/E3 | Ewoosoft Co., Ltd | LLZ | Class II | |
| K211757 | Simplify Disc | NuVasive Inc | QLQ | Class II |