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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K243097 | RM STAR EX with RMS Needle | Bomtech Electronics Co., Ltd. | GEI | Class II | |
| K243037 | Diode Laser System model Dawn-S | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | GEX | Class II | |
| K240517 | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte., Ltd. | ONB | Class II | |
| K233252 | Straumann CARES Visual and Nova Dental CAD | Straumann USA, LLC | PNP | Class II | |
| K232966 | Fisiowarm 7.0 | Golden Star Company Limited | PBX | Class II | |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater Inc | SBF | Class II | |
| K242434 | Insulin Syringes | Chirana T. Injecta | FMF | Class II | |
| K243693 | NEO Pedicle Screw System™ | Neo Medical, Inc. | NKB | Class II | |
| K243248 | Inhance Intact™ | Depuy Ireland UC | PKC | Class II | |
| K243177 | Sacs Pro | Elastimed | IRP | Class II | |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd | EBI | Class II | |
| K242948 | Adora DRFi (04550010) | NRT X-Ray a/S | JAA | Class II | |
| K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical LLC | HRS | Class II | |
| K242797 | OsteoFlo HydroFiber | Surgentec LLC | MQV | Class II | |
| K242782 | GlassBone Granules | Noraker | MQV | Class II | |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | Belmont Medical Technologies | FRN | Class II | |
| K242573 | NIDO Baby Magnetic Resonance Imaging System | Jiangsu Lici Medical Device Co., Ltd. | LNH | Class II | |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | JAK | Class II | |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd | DXT | Class II | |
| K242091 | Bolo Button System | Fusion Orthopedics, LLC | HTN | Class II | |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | FMF | Class II | |
| K241288 | Noxturnal Web | Nox Medical Ehf | OLV | Class II | |
| K241091 | SIMEOX 200 Airway Clearance Device | Inogen, Inc | SDT | Class II | |
| K240975 | Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300) | Beijing Taktvoll Technology Co., Ltd. | GEI | Class II | |
| K240890 | PanopticAI Vital Signs | PanopticAI Technologies Limited | QME | Class II | |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; | Jiangxi Medex Technology Co.,Ltd | GEX | Class II | |
| K243147 | LGO-Surgical Laser Fibers | Light Guide Optics International Ltd. | GEX | Class II | |
| K243085 | IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) | Zhuzhou Goldenhot Medical Technology Co.,Ltd | OHT | Class II | |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | EKX | Class I | |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | BioFire Diagnostics, LLC | PEN | Class II | |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc | MOS | Class II | |
| K243671 | ExcelsiusGPS® Instruments | Globus Medical, Inc. | OLO | Class II | |
| K243629 | Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K243607 | Moda-flx Hemodialysis System™ Cartridge (102121-001 ) | Diality, Inc. | FJK | Class II | |
| K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | Bonebridge AG | HRS | Class II | |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer GmbH | MBH | Class II | |
| K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC | QLY | Class II | |
| K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | Shenzhen Siken 3D Technology Development Co., Ltd. | OHS | Class II | |
| K243024 | Cellbrick Knee Spacer | United Orthopedic Corp. | JWH | Class II | |
| K242953 | KIDS Arterial Filters | Corcym Inc. | DTM | Class II | |
| K242929 | Fas Aligner System | Xplora 3D Europe SL | NXC | Class II | |
| K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | Envision Endoscopy Inc. | OCZ | Class II | |
| K242688 | Finiff System | Skingrab | GEI | Class II | |
| K242644 | SENDERO MAX Delivery Catheter | Okami Medical Inc. | DQY | Class II | |
| K242628 | Scooter (PS30) | Lichtmega Technology Co., Ltd. | INI | Class II | |
| K242599 | aprevo® Digital Planning | Carlsmed, Inc. | LLZ | Class II | |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | EBF | Class II | |
| K242534 | HandPICO Fractional Laser Handpiece Tip | Vydence Medical | GEX | Class II | |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | KLE | Class II |