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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | LCP | Class II | |
| K171494 | TroClose1200, TroClose1200 Cannula | Gordian Surgical | GAM | Class II | |
| K170992 | AcuNav V 10F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | |
| K170850 | Alma Q | Alma Lasers Ltd. | GEX | Class II | |
| K170849 | SIMPLANT Guide | Dentsply Sirona Inc | NDP | Class I | |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Depuy (Ireland) | JWH | Class II | |
| K170803 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products Inc | NEU | Class II | |
| K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | OVE | Class II | |
| K170499 | sensiLift | El Global Trade Ltd. | PAY | Class II | |
| K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell | Microport Orthopedics Inc. | MBH | Class II | |
| K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | OBJ | Class II | |
| K170198 | Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White) | Medtronic, Inc. | KGO | Class I | |
| K163632 | Katalyst Cyclophotocoagulation Probe | Katalyst Surgical, LLC | LQJ | Class II | |
| K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | DXT | Class II | |
| K162826 | Encore Neutral | RyMed Technologies, LLC | FPA | Class II | |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | FUJIFILM Healthcare Americas Corporation | FDS | Class II | |
| K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay | Hologic, Inc. | OQO | Class II | |
| K162459 | AccuPoint Electrode | Microprobes for Life Science, Inc. dba Neuron | GZL | Class II | |
| K161177 | Axiom PX | Anthogyr SAS | DZE | Class II | |
| K171484 | hema-screen SPECIFIC Gold | Immunostics, Inc. | KHE | Class II | |
| K171231 | Endoform Topical Matrix | AROA Biosurgery Inc. | KGN | Unclassified | |
| K170966 | Tonoport VI | PAR MEDIZINTECHNIK GmbH & Co. KG | DXN | Class II | |
| K170878 | Vivid S60N, Vivid S70N | GE Healthcare | IYN | Class II | |
| K170848 | Alzair Allergy Blocker | Nasaleze International, Ltd. | NUP | Class II | |
| K170847 | EchoPAC Software Only, EchoPAC Plug-in | GE Healthcare | LLZ | Class II | |
| K170457 | EVOS Small Fragment Lower Extremity Plates | Smith & Nephew, Inc. | HRS | Class II | |
| K170396 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK | Class II | |
| K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | NJM | Class II | |
| K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular Inc | PNO | Class II | |
| K162719 | iTotal® Hip Replacement System | ConforMIS, Inc. | LPH | Class II | |
| K161970 | Follicle Aspiration Set | Vitrolife Sweden AB | MQE | Class II | |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | Immunalysis Corporation | DJG | Class II | |
| K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical Inc. | FCG | Class II | |
| K171468 | FUSE Spinal System | Medtronic Sofamor Danek | MAX | Class II | |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette | Medtronic, Inc. | OTD | Class II | |
| K171426 | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree | Intuitive Surgical, Inc. | NAY | Class II | |
| K171111 | Sculpsure | Cynosure, LLC | PKT | Class II | |
| K170713 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | NAY | Class II | |
| K170325 | Secret RF | Ilooda Co,., Ltd. | GEI | Class II | |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight LLC | ILY | Class II | |
| K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K160753 | COOK Vacuum Pump | William A. Cook Australia Pty, Ltd. | MQG | Class II | |
| K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System | Medyssey USA | NKB | Class II | |
| K171437 | SonoSite X-Porte Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K171418 | 1417WCC_127um and1417WCC_140um | Rayence Co., Ltd. | MQB | Class II | |
| K171417 | 1417WGC_127um and 1417WGC_140um | Rayence Co., Ltd. | MQB | Class II | |
| K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Healthcare | IYN | Class II | |
| K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | MAX | Class II | |
| K162755 | Picocare | WONTECH Co., Ltd. | GEX | Class II |