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 |
|---|---|---|---|---|---|
| K213194 | HD Mediastinoscope | Karl Storz Endoscopy-America, Inc. | EWY | Class II | |
| K211173 | maxmorespine Bipolar Electrodes | Hoogland Spine Products GmbH | GEI | Class II | |
| K201788 | EDEN Spinal Fixation System | Jmt Co., Ltd. | NKB | Class II | |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | ESW | Class II | |
| K221192 | Disposable Nitrile Powder-Free Examination Gloves | Shandong Maida Medical Technology Co., Ltd. | LZA | Class I | |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | LYY | Class I | |
| K221008 | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) | Shanghai Handy Medical Equipment Co., Ltd. | MUH | Class II | |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | Sofradim Production | FTL | Class II | |
| K220413 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical USA LLC | QPP | Class II | |
| K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | |
| K213739 | Nitrile Examination Gloves | Hangzhou Runheng Medical Co., Ltd. | LZA | Class I | |
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote | Edwards Lifesciences LLC | DQK | Class II | |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | EWO | Class II | |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | ConvaTec Limited | GBM | Class II | |
| K213274 | Qlicksmart BladeFlask UNIVERSAL | Qlicksmart Pty., Ltd. | MMK | Class II | |
| K213230 | T3 Platform Software | Etiometry Inc. | PPW | Class II | |
| K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) | Huizhou Xiaoou Technology Co., Ltd. | DQA | Class II | |
| K211877 | Klassic Knee System | Total Joint Orthopedics, Inc. | JWH | Class II | |
| K220856 | Vial Adapter Ø13mm | Avenir Performance Europeenne Medical (Apem) | LHI | Class II | |
| K220800 | Venue Go | GE Healthcare | IYN | Class II | |
| K220482 | Sherlock | Open Implants | NHA | Class II | |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | Nu Vasive, Incorporated | MAX | Class II | |
| K220270 | Aspirex Thrombectomy System | C.R. Bard Inc | QEW | Class II | |
| K213665 | Syngo Carbon Space VA20A | Siemens Healthcare GmbH | LLZ | Class II | |
| K213220 | Revaree Plus Vaginal Suppositories | Farma-Derma S.r.l. | NUC | Class II | |
| K211979 | Lumenis Y&R Laser System | Lumenis Ltd | GEX | Class II | |
| K211148 | CORE-Trocar | Incore Co., Ltd. | GCJ | Class II | |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | MTD | Class II | |
| K203791 | Stainless Turbine | Nakanishi Inc. | EFB | Class I | |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | EMD Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | HBF | Class II | |
| K221470 | Langston dual lumen catheter | Vascular Solutions LLC | DQO | Class II | |
| K221465 | Baby Gorilla/Gorilla Plating System | Paragon 28 | HRS | Class II | |
| K221463 | ElucidVivo A.3 | Elucid Bioimaging | LLZ | Class II | |
| K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | Varian Medical Systems, Inc. | IYE | Class II | |
| K221217 | SPY Laparoscope | Stryker Corp. | GCJ | Class II | |
| K221117 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K220813 | Art-Plan | Therapanacea | QKB | Class II | |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | Ceragem Co., Ltd. | JFB | Class II | |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | restor3d, Inc. | MAX | Class II | |
| K220431 | Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | |
| K220210 | Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd | ODC | Class II | |
| K213255 | CipherOx CRI Tablet | Flashback Technologies, Inc. | PPW | Class II | |
| K213197 | MyOnyx System | Thought Technology Ltd. | IPF | Class II | |
| K213037 | IDx-DR v2.3 | Digital Diagnostics Inc. | PIB | Class II | |
| K212871 | Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode | Galvanize Therapeutics | OAB | Class II | |
| K211099 | Freeze’n Clear Skin Clinic Warts & Tags | Cryoconcepts LP | GEH | Class II | |
| DEN210004 | Zuno Smart Sterilization Container | Zuno Medical, Inc. | QJT | Class II | |
| K221345 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K221226 | 1st Glove Blue Nitrile Examination Gloves Powder Free | Koove Iot Pvt. Ltd | LZA | Class I | |
| K221186 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | LZA | Class I |