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 |
|---|---|---|---|---|---|
| K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | Vioptix, Inc. | MUD | Class II | |
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix LLC | PDQ | Class II | |
| K243391 | AISight Dx | Pathai | QKQ | Class II | |
| K243275 | Equinoxe® Scapula Fracture System | Exactech, Inc. | HRS | Class II | |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | FRG | Class II | |
| K243175 | Disposable Intermittent Catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | EZD | Class II | |
| K243079 | NeuroTrac® MyoPlus Pro (MYO120U) | Verity Medical, Ltd. | KPI | Class II | |
| K242846 | Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co.,Ltd | KNG | Class II | |
| K251725 | ANAX™ OCT Spinal System | CG MedTech Co., Ltd. | NKG | Class II | |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Smith & Nephew, Inc. | MBI | Class II | |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K251606 | Power Wheelchair (D26) | Anhui JBH Medical Apparatus Co., Ltd | ITI | Class II | |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | MAX | Class II | |
| K250966 | CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | PBF | Class II | |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K250747 | Globe® Pulsed Field System | KARDIUM Inc. | DQK | Class II | |
| K250329 | GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. | KGN | Unclassified | |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings (Pty) Ltd | DQY | Class II | |
| K243112 | Curapuls 670 | Enraf-Nonius B.V. | IMJ | Class II | |
| K242845 | EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. | FGE | Class II | |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | FMF | Class II | |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | OVD | Class II | |
| K251362 | PediFlex™ Flexible Nail System | Orthopediatrics Corp | HTY | Class II | |
| K251358 | Bridge Plus Occlusion Balloon (590-002) | Philips Image Guided Therapy Devices | MJN | Class II | |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | Spectrum Medical Inc | KFM | Class II | |
| K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | SFE | Class II | |
| K243009 | Mist Ic | Imagine Milling Technologies, LLC | NHA | Class II | |
| K251570 | Hippocampe Marathon and Trail | Vipamat SARL | IQC | Class II | |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | EBG | Class II | |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem S.r.l. | JTN | Class II | |
| K250862 | Evis Exera III Bronchovideoscope (Olympus Bf-Xp190); Evis Exera III Bronchovideoscope (Olympus Bf-P190); Evis Exera III Bronchovideoscope (Olympus Bf-Xt190); Bronchovideoscope (Olympus Bf-H1100); Bronchovideoscope (Olympus Bf-1Th1100) | Olympus Medical Systems Corp. | EOQ | Class II | |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | |
| K250143 | Digital Prism Correction Feature (DPCF) | Apple Inc. | SCW | Class I | |
| K243339 | WiTOF | Idmed | KOI | Class II | |
| K243142 | Cranial 4Pi Immobilization | Brainlab, Inc. | IYE | Class II | |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | NQQ | Class II | |
| K251567 | NovoSorb BTM | Polynovo Biomaterials Pty Ltd | QSZ | Unclassified | |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | QJP | Class II | |
| K251258 | MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula | Medtronic, Inc. | DWF | Class II | |
| K251248 | Electric Wheelchair (Qdwp-A01,qdwp-B02) | Jinhua Qidian Vehicle Co. Ltd | ITI | Class II | |
| K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | QJP | Class II | |
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. C/O Linda Braddon, PhD | OXF | Class II | |
| K251114 | FloPatch FP120 | Flosonics Medical | DPW | Class II | |
| K250968 | PathPresenter Clinical Viewer | Pathpresenter Corp | QKQ | Class II | |
| K250880 | LED Light Mask (A093) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. | OHS | Class II |