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 |
|---|---|---|---|---|---|
| K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | |
| K192798 | Zimmer Segmental System | Zimmer GmbH | KRO | Class II | |
| K203321 | Cystoject Syringe Lever | Urogen Pharma Ltd. | QBL | Class II | |
| K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co. Ltd | FED | Class II | |
| K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | Viora, Ltd. | PBX | Class II | |
| K201893 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | FXX | Class II | |
| K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | LHI | Class II | |
| K200781 | Infrared Body Thermometer | Heitaida Technology Co., Ltd. | FLL | Class II | |
| K203291 | CD Horizon Spinal System Instruments | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K202983 | easy Hairfull | Y&j Bio Co., Ltd. | OAP | Class II | |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | FDT | Class II | |
| K202648 | Biofeedback Nerve and Muscle Stimulator | Shenzhen Konmed Technology Co., Ltd | IPF | Class II | |
| K202631 | iHelmet Laser Comb | Slinph Technologies Co., Ltd | OAP | Class II | |
| K202623 | Novapak Nasal Sinus Packing and Stent | Medtronic Xomed, Inc. | LYA | Class I | |
| K202189 | Graffiti | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K201865 | Biomonitor III, Biomonitor IIIm | BIOTRONIK AG | MXD | Class II | |
| K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | Medentika GmbH | NHA | Class II | |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation | Smith & Nephew, Inc. | KTT | Class II | |
| K200951 | Accu-Joint Hemi Implant | Accufix Surgical, Inc. | KWD | Class II | |
| K200196 | Taperloc® Complete Hip Stems | Biomet Orthopedics, Inc. | LZO | Class II | |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | QKM | Class II | |
| K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | HQF | Class II | |
| K202701 | GIA Stapler with Tri-Staple Technology | Medtronic, Inc. | GDW | Class II | |
| K202588 | BNA Platform | Elminda, Ltd. | OLU | Class II | |
| K202330 | Impella XR Sheath Set | Abiomed, Inc. | DYB | Class II | |
| K202173 | Pulse Oximeter | Shenzhen AOJ Medical Technology Co., Ltd. | DQA | Class II | |
| K201864 | YUWELL Infrared Thermometer | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | FLL | Class II | |
| K201384 | Pulse Oximeter | Shenzhen Raysintone Technology Co., Ltd. | DQA | Class II | |
| K201183 | Vortex Radial Spray Catheter | CSA Medical | GEH | Class II | |
| K201039 | HepaFat-AI | Resonance Health Analysis Services Pty Ltd | LNH | Class II | |
| K201003 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | HEB | Class II | |
| K200884 | B-Secur HeartKey Software Library | B-Secur Limited | DPS | Class II | |
| K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | Visco Vision Inc. | LPL | Class II | |
| K202599 | Transtek Wrist Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K203016 | Dvt-2600 | Daesung Maref Co.,Ltd | JOW | Class II | |
| K203249 | Nucleus.io | Nucleushealth, LLC | LLZ | Class II | |
| K202837 | GoSpiro | Monitored Therapeutics, Inc. | BZG | Class II | |
| K202487 | HealthJOINT | Zebra Medical Vision, Ltd. | LLZ | Class II | |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis Inc. | PLV | Class II | |
| K201541 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | |
| K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corporation | ELC | Class II | |
| K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | |
| K200789 | LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K200716 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | DXN | Class II | |
| K200646 | TubeClear System | Actuated Medical, Inc. | KNT | Class II | |
| K200442 | InBody | InBody Co, Ltd. | DXN | Class II | |
| K193646 | Dynamic Gas Scavenging System 2 (DGSS - 2) | Anesthetic Gas Reclamation, Inc. | CBN | Class II | |
| K193508 | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | Oxoid Limited (Part of Thermo Fisher Scientific) | JTN | Class II | |
| K193444 | Vagisan MoistCream Cremolum | Dr. August Wolff GmbH & Co. KG Arzneimittel | NUC | Class II | |
| K203367 | LineSider™ Spinal System | Integrity Implants, Inc. | NKB | Class II |