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 |
|---|---|---|---|---|---|
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | FPA | Class II | |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Burmoos GmbH | EFB | Class I | |
| K241922 | Myomics | Phantomics, Inc. | QIH | Class II | |
| K241717 | E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited | PSY | Class II | |
| K241617 | Durex Polyisoprene Condom | Rb Health (Us), LLC | MOL | Class II | |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui JBH Medical Apparatus Co., Ltd | IOR | Class I | |
| K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co 1, LLC. | PHR | Class II | |
| K250021 | Rotium | Nanofiber Solutions LLC | OWW | Class II | |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co.,Ltd | NFT | Class II | |
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific Oy | NGZ | Class II | |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | BrosMed Medical Co.,Ltd. | LIT | Class II | |
| K243543 | microINR System | Iline Microsystems S.L. | GJS | Class II | |
| K243357 | CastleLoc Pectus Bar System | L&K Biomed Co.,Ltd. | HRS | Class II | |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | Icotec AG | NKB | Class II | |
| K242175 | XOD Diathermia Radiofrequency Device | XOD Inc | PBX | Class II | |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical AB | KNW | Class II | |
| K241620 | ChestView US | Gleamer SAS | MYN | Class II | |
| K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt, Ltd. | FBK | Class II | |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems Inc. | JKA | Class II | |
| K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | DSY | Class II | |
| K250346 | BonVie+ | Elute, Inc. | MQV | Class II | |
| K250281 | Deka Lotus | El.En S.p.A. | ONF | Class II | |
| K250202 | Aventus Thrombectomy System | Inquis Medical, Inc. | QEW | Class II | |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze | NRY | Class II | |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | Sterilance Medical (Suzhou) Inc. | FMK | Class II | |
| K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | Sterilance Medical (Suzhou) Inc. | QRK | Class II | |
| K243918 | Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular LLC | GEI | Class II | |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K241587 | pilot TLS | Vygon | LJS | Class II | |
| K241576 | Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Nipro Vascular Innovations Americas, Inc. | OGZ | Class II | |
| K241546 | aiCockpit AI Viewer | Fovia, Inc. | LLZ | Class II | |
| K241222 | Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics Ltd. | QIH | Class II | |
| K250348 | JLK-AILink | JLK, Inc. | LLZ | Class II | |
| K250238 | WasherCap™ Fixation System | Abanza Tecnomed, S.L. | MBI | Class II | |
| K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K243446 | 3Dxr | GE Medical Systems SCS | OWB | Class II | |
| K243276 | ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K242967 | Loss of Pulse Detection | Fitbit LLC | SDY | Class II | |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea SAS | MUJ | Class II | |
| K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | NGX | Class II | |
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | |
| K244010 | ExamVue Apex | JPI Healthcare Co., Ltd | MQB | Class II | |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | LZC | Class I | |
| K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | QJI | Class II | |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | Alembic LLC | NRY | Class II | |
| K243035 | Ulthera® System | Merz North America, Inc. | OHV | Class II | |
| K242994 | OncoStudio (OS-01) | Oncosoft Inc. | QKB | Class II | |
| K241703 | SD Implant System | ARUM DENTISTRY Co., Ltd. | DZE | Class II | |
| K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co.,Ltd | FRG | Class II | |
| K250218 | Xpert® FII & FV | Cepheid | NPR | Class II |