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 |
|---|---|---|---|---|---|
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.p.A. | PHX | Class II | |
| K212300 | Pulse Oximeter | Shenzhen Mericonn Technology Co., Ltd. | DQA | Class II | |
| K211855 | Ion Facet Screw System | Surgentec LLC | MRW | Unclassified | |
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares | Canadian Pioneer Medical Technology Corporation | GEX | Class II | |
| K211711 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK | Class II | |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Okamoto U.S.A., Inc. | MOL | Class II | |
| K203150 | Cool-tip RF Ablation System E Series | Medtronic, Inc. | GEI | Class II | |
| K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | OLW | Class II | |
| K220384 | ArtiSential Laparoscopic Instruments-Electrodes | LivsMed Inc. | GEI | Class II | |
| K220028 | NightOwl | Ectosense NV | MNR | Class II | |
| K214100 | Luminice | Premier North America, Inc | NFO | Class II | |
| K214094 | ROKI Surgical Mask | Roki Co., Ltd. | FXX | Class II | |
| K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai Pty, Ltd. | QFM | Class II | |
| K212949 | Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use | Henan Nursecare Biotechnology Co., Ltd. | MEG | Class II | |
| K211798 | Cleaner Plus Thrombectomy System | Argon Medical Devices, Inc | QEW | Class II | |
| K211645 | Epione | Quantum Surgical SAS | JAK | Class II | |
| K211510 | uLab Systems Dental Aligner Kit | uLab Systems, Inc | NXC | Class II | |
| K211320 | CAPRI Corpectomy Cage System | K2M, Inc | PLR | Class II | |
| K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing | 3M Healthcare Business Group | FRO | Unclassified | |
| K202845 | Bodygard SFS Surgical Gown Level 3 | Feliks Plastik Laminasyon ve Ambalaj Malzemeleri Sanayi | FYA | Class II | |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc | PLF | Class II | |
| K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd | LLZ | Class II | |
| K214102 | Glidewell Appliance Resin, Hard/Soft | Prismatik Dentalcraft, Inc. | MQC | Unclassified | |
| K213654 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | NKG | Class II | |
| K213599 | SuperLine | Dentium Co., Ltd. | DZE | Class II | |
| K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | HIF | Class II | |
| K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FBK | Class II | |
| K212378 | Arsenal Ankle Plating System | Trilliant Surgical LLC | HRS | Class II | |
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | GZF | Class II | |
| DEN210034 | ONE Male Condom | Global Protection Corp. | QRZ | Class II | |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products Inc. | EBZ | Class II | |
| K213991 | Enbio S | Enbio Group AG | FLE | Class II | |
| K213392 | INLIANT Surgical Navigation System | Navigate Surgical Technologies Inc. | PLV | Class II | |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | Ethicon, Inc | NEW | Class II | |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System | Shanghai Seegen Photoelectric Technology Co., Ltd | FGB | Class II | |
| K213548 | Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy | Mercator Medical (Thailand) Ltd. | LZA | Class I | |
| K213500 | TMG Nitrile Powder Free Examination Glove | Thai Medical Glove Co., Ltd. | LZA | Class I | |
| K203548 | EndoArmor™ + Surgical Gown | Boston Scientific Corporation | FYA | Class II | |
| K220232 | Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange | Megine Industries Sdn Bhd | LZA | Class I | |
| K213724 | Medical Surgical Mask | Hunan Zhenheyikang Medical Instrument Co., Ltd. | FXX | Class II | |
| K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs | Mah Sing Healthcare Sdn Bhd | LZA | Class I | |
| K213912 | Disposable Medical Nitrile Examination Gloves | Jiangsu Maolin Medical Technology Co., Ltd. | LZA | Class I | |
| K213600 | Medical nitrile examination gloves (Model: SH001) | Jiangxi Sanhao Medical Instruments Co.,Ltd | LZA | Class I | |
| K213286 | EONS Nitrile Examination Gloves Powder Free | Eons Gloves (Thailand) Co., Ltd. | LZA | Class I | |
| K213091 | Well-Life TENS/EMS/Heating Stimulator | Well-Life Healthcare Limited | NUH | Class II | |
| K212998 | Powder Free Nitrile Examination Gloves (White, Blue and Black) | Alcatron Gloves Factory | LZA | Class I | |
| K212935 | Air Pressure Foot Massager | Xiamen Simo Electronic Co., Ltd | IRP | Class II | |
| K212863 | Surgical Face Mask | Taiwan Comfort Champ Manufacturing Co., Ltd. | FXX | Class II | |
| K212366 | Heartland Health Surgical Mask | Heartland Health Products | FXX | Class II | |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria | Hycor Biomedical | DHB | Class II |