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 |
|---|---|---|---|---|---|
| K214005 | Zirconia Dental Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | EIH | Class II | |
| K214003 | Dental Zirconia Pre-shaded Block | Shenzhen Yurucheng Dental Materials Co., Ltd. | EIH | Class II | |
| K213999 | Deep Learning Image Reconstruction | GE Healthcare | JAK | Class II | |
| K213688 | Nitrile Examination Gloves (Model: ZMG1351) | Wuhan Zonsen Medical Products Co., Ltd | LZA | Class I | |
| K213634 | Vinyl/Nitrile Blend Exam Glove | Dezhou Hengchang Medical Technology Co., Ltd. | LYZ | Class I | |
| K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K213440 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs | Luliang Hongruida Health Protection Technology Co., Ltd. | LZA | Class I | |
| K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | QFM | Class II | |
| K213306 | Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs | Zibo Sinocare Plastic Products Co., Ltd. | LZA | Class I | |
| K213079 | Ear Thermometer, Model ET001 | Guangzhou Berrcom Medical Device Co., Ltd | FLL | Class II | |
| K213057 | ExamVue Duo | JPI Healthcare Co., Ltd | KPR | Class II | |
| K212627 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | NKB | Class II | |
| K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | LCX | Class II | |
| K212212 | Multitom Rax with True2scale Body Scan Option | Siemens Medical Solutions | OWB | Class II | |
| K211746 | Pocket Ultrasound System | Guangdong Youkey Medical Co., Ltd. | IYN | Class II | |
| K202644 | Acetaminophen | Sekisui Diagnostics P.E.I. Inc. | LDP | Class II | |
| K201510 | Traufix osteosynthesis, osteotomy, and arthrodesis devices | Fixier S.A. de C.V. | HRS | Class II | |
| K220277 | Digital Intraoral X-ray Sensor | Shenzhen Xpectvision Technology Co., Ltd. | MUH | Class II | |
| K220150 | TENS & PMS (Model: SM9126) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | |
| K220137 | Lunderquist Extra Stiff Wire Guide | William Cook Europe ApS | DQX | Class II | |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | Pollogen Ltd | GEI | Class II | |
| K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | QRL | Class II | |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments Inc. | HTY | Class II | |
| K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX | GE Healthcare Information Technologies | DQK | Class II | |
| K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | |
| K213689 | Voluson P6, Voluson P8 | GE Healthcare | IYN | Class II | |
| K213647 | Durex Patronus Wide | Rb Health (Us), LLC | HIS | Class II | |
| K213625 | Vinyl Examination Gloves | Dezhou Hengchang Medical Technology Co., Ltd. | LYZ | Class I | |
| K213107 | Powder Free Blue Nitrile Examination Gloves | Novid Ppe Sdn. Bhd. | LZA | Class I | |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis US Corp. | DQO | Class II | |
| K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | FRA | Class II | |
| K212586 | Amazing+ | Amazing Rubber Products Pvt. Ltd | LZA | Class I | |
| K211679 | Xtractor device | Xcardia Innovation, Ltd. | DRE | Class II | |
| K211212 | LoFric Elle | Dentsply Sirona Inc | EZD | Class II | |
| K210864 | Safety Pen Needle | Sandstone Medical (Suzhou) Inc. | FMI | Class II | |
| K210208 | Titan Condoms | Titan Condoms | HIS | Class II | |
| K220419 | Apapro Desensitizer | Sangi Co., Ltd. | LBH | Class II | |
| K220147 | Aspiron S ACP System | CG MedTech Co., Ltd. | KWQ | Class II | |
| K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | |
| K214044 | 14Hq901g-B | LG Electronics.Inc | MQB | Class II | |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | Bio Compression Systems, Inc. | IRP | Class II | |
| K213186 | NovoFlow Reinforced Ureteral Stent | MEDLINE INDUSTRIES, LP - Northfield | FAD | Class II | |
| K212930 | LumiVy Lumbar IBF System | VY Spine, LLC | MAX | Class II | |
| K212886 | Broncoflex Agile, Broncoflex Vortex, Screeni | Axess Vision Technology | EOQ | Class II | |
| K210636 | Morpheus | S4S UK, Ltd. | LRK | Class II | |
| K210229 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | MEG | Class II | |
| K203234 | t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K213622 | Cionic Neural Sleeve NS-100 | Cionic | GZI | Class II | |
| K213606 | EvoEndo Single-Use Endoscopy System | Evoendo, Inc. | FDS | Class II | |
| K212011 | Vinyl Powder Free Examination Glove | Top Glove Vietnam Company Limited | LYZ | Class I |